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AI-enabled medical devices in the ARTG

A list of Artificial Intelligence (AI) enabled medical devices included in the Australian Register of Therapeutic Goods (ARTG)

Last updated

The following medical devices in the Australian Register of Therapeutic Goods (ARTG) incorporate AI or machine learning (ML) technologies.

Note on limitations

This list does not capture all medical devices that may incorporate AI or ML technology. The search criteria only identify devices where:

  • these terms appear in the product name or intended purpose
  • this has been reported by the sponsor after March 2025.

If you are the sponsor of an AI-enabled medical device in the ARTG that you wish to have included on this list, contact Digital.Devices@tga.gov.au
 

ARTG IDManufacturerSponsor  GMDN TermClassificationIntended Purpose
195288RaySearch Laboratories AB (publ)Emergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.Class IIbRayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorised intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs. 
RayStation is a software system for radiation therapy, ablation therapy and medical oncology. Based on user input, RayStation visualizes and proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified staff trained in using the system.
301721Samsung Medison Co LtdQuantum Health GroupA general-purpose diagnostic ultrasound imaging system designed exclusively for use in a wide variety of both extracorporeal and/or intracorporeal (endosonography or endoscopic) body imaging procedures. A general-purpose system supports a wide variety of transducers and related application software packages allowing for the collection, display and analysis of ultrasound information. Usages are, e.g. general-purpose imaging, cardiac, OB/GYN, endoscopy, breast, prostate, vascular, intra-surgical, Doppler or colour Doppler, depending on the operating system specific software packages and compatible ultrasound transducers.Class IIaA general purpose, mobile, software controlled diagnostic Ultrasound system. Its function is to acquire ultrasound data and to display data as 2D mode, M Mode, Colour Doppler Imaging, Power Doppler imaging, harmonic imaging and PW spectral Doppler mode on the LCD system display. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by qualified health professionals. The clinical applications include; abdomen, OB, gynaecology, contrast agent, small parts, vascular, musculo-skeletal, paediatric abdomen, adult cardiac, paediatric cardiology, TCD, urology, cardiac, thoracic, ophthalmic and dermatology applications.
312072Medis Medical Imaging System bvIntervene Medical Pty LtdAn individual software program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to an analyser or an analyser system configuration. A basic set of applications programs and routines are included with such computer-controlled analysers and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaMedis QFR XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to to quantitatively assess X-ray angiographic images the chambers of the heart and of the blood vessels, for use on individual patients with cardiovascular disease. 
• The QCA measurements can be applied to individual patients with coronary artery disease for measurements in the coronary arteries having a vessel diameter > 1.5mm, 
• The QLV and QRV measurements can be applied to individual patients with left or right ventricular disfunction as a result of cardiovascular disease or congenital heart disease,
• The QVA measurements can be applied to individual patients with peripheral artery disease for measurements in the carotid, femoral, and aortoiliac arteries, they are only intended for use by the responsible clinicians.
• The QFR measurements can be applied to intermediate coronary lesions in individual patients with stable angina. The QFR measurement have not been evaluated and therefore should not be applied for non-coronary arteries, in paediatric patients, and cardiac patients with the following conditions: 1) Tachycardia with frequency above 100 bpm,2)Systolic aortic resting blood pressure below 75 mm Hg, 3) Atrial fibrillation.
316044Aidoc Medical LtdACRA Regulatory Services Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class 1BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of radiological images. 
The device is intended to assist hospital networks and trained medical specialists in workflow triage by flagging and communication of suspected positive findings the following indications: 
1.Intracranial Hemorrhage (ICH) triage, non-enhanced head CT.
2.Cervical Spine Fracture (CSF) triage, non-enhanced cervical spine CT, bone kernel only.
3.Pulmonary Embolism (PE) triage, CTPA.
4.Vessel Occlusion (VO) triage, head CTA (VO on M1).
5.Intra-abdominal free gas (IFG) triage, abdomen CT. 
6.Incidental Pulmonary Embolism (iPE) triage, chest CT.
7.Rib Fracture (RibFx) triage, chest CT (with or without contrast).
8.Brain Aneurism (BA) triage, Head CTA.
9.Pulmonary Nodules (PN) QC, chest and abdomen CT (with and without contrast).
10.Pneumothorax (Ptx) triage, frontal chest X-Ray.
11. Vertically malpositioned endotracheal tube in relation to the carina (ETT)
12. Aortic Dissection (AD)
13. Vertebral Compression Fractures (VCFx)
BriefCase uses an artificial intelligence algorithm to analyse images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification.  The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on the user’s professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
329820Clarius Mobile Health CorpClarius Mobile Health Australia Pty LtdA battery-powered, hand-held assembly of devices designed for collection, display, and analysis of ultrasound information during a variety of extracorporeal ultrasound imaging procedures (i.e., non-dedicated); it is not intended for intracorporeal ultrasound imaging. It typically consists of an ultrasound transducer, data processing unit, and graphical display contained within a compact unit, and may include a line-powered charging station.Class IIaThe Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic1 , fetal, abdominal, intraoperative (non neurological), pediatric, small organ, cephalic (adult), trans-rectal, transvaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.
The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.
Clarius MSK AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles’ tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L7 HD3 and L15 HD3). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment.
Clarius Bladder AI is intended for semi-automatic non-invasive measurements of bladder volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and phased array scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Bladder AI is indicated for use in adult patients only.
Clarius OB AI is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear scanner). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius OB AI is indicated for use in adult patients only.
Clarius Prostate AI is intended for semi-automatic measurements of prostate volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and endo-cavitary scanners).   The user shall be a healthcare professional trained and qualified in ultrasound.  The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Prostate AI is intended for use in adult male patients only.
Clarius Median Nerve AI is intended for segmentation and semi-automatic non-invasive measurements of the median nerve cross-sectional area on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., linear array scanners).  The user shall be a healthcare professional trained and qualified in ultrasound.  The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Median Nerve AI is intended for use in adult patients only.
335634Oral Tech Al Pty LtdOral Tech Al Pty LtdAn individual dedicated software program, routines and/or algorithms used as or in an information system to receive, collect, store, assist in data analysis/management, display, output and distribute information within one healthcare facility or among many healthcare facilities to support the administrative and clinical activities associated with the provision and utilization of that activity. It is typically supplied for installation into a dedicated information system or existing mainframe or decentralized computers/networks.Class 1Smilo is a smart device Application to provide oral health awareness. Smilo users upload images of their teeth and gums, which are processed by machine learning to produce an “Oral Health Rating” depending on the presence or absence of dental caries and periodontitis. Smilo does not provide a diagnosis. It provides dental awareness for users who are advised to visit a Dentist for further advice and treatment within clinically-recommended timeframes.
In addition to the Oral Health Rating function, the Application also provides:
• a “Dental Awareness and Education” function where articles on good oral health maintenance habits are regularly uploaded;
• a “Discussion Forum” where registered users may ask questions relating to oral health and the health professional administrators provide responses; 
• a “Design my Smile” feature where an image of the user’s smile is assessed by Artificial Intelligence and generates a picture of the user’s optimal teeth and gum appearance with good oral health care and potentially maintenance through a registered Dentist.
Oral Health Ratings:
Green-Suggests your teeth and gums are in a stable- excellent condition. There is no or minimal probability of dental caries and periodontitis. Please watch and monitor your oral/dental health for any visible changes, pain, tenderness and if you notice any changes to the surface of your teeth or gums. You should still visit the dentist within 6-12 months from the date of your last visit.
Orange-Suggests that your teeth and gums need to be seen by a dentist. There is an above average probability of dental caries and/or gum disease. Please see the dentist as soon as possible to be investigated further.
Red-Suggests that your teeth and gums are in a poor state. There is a high probability of dental caries and gum disease. Please see your dentist urgently.
340685Sydney Neuroimaging Analysis Centre Pty LtdSydney Neuroimaging Analysis Centre Pty LtdAn application software program, routines, and/or algorithms intended to be used as part of a medical image management system to receive, collect, store, and display a broad range of medical imaging/video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). It is installed into a dedicated medical image management system, existing server, and/or decentralized computers.Class 1The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health informatics. Torana™ Medical Imaging Gateway can be configured by the users to facilitate custom data workflows that integrate PACS, RIS, databases, and image analysis services. Example usages of  Torana™ Medical Imaging Gateway include the automatic routing/archiving of newly acquired medical scans or the submission of medical scans for AI analysis to a remote cloud server.
345076Lunit IncAA-Med Pty LtdAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIaLunit INSIGHT MMG is a Computer-Assisted Detection/Diagnosis (CAD) software device that assists interpreting physicians in the interpretation of mammograms. The device has been designed to automatically analyze digital mammograms via deep learning technology.
355336Precision AI Pty LtdPrecision AI Pty LtdA non-sterile, custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.Class 1The Precision AI Surgical Guides are patient specific guides (or instruments) intended to assist surgeons with the task of accurately recreating the pre-operative plan in orthopaedic surgeries.
355602Precision AI Pty LtdPrecision AI Pty LtdAn individual software application program intended to add specific computer-assisted display, processing, and/or analysis capabilities to a computer and/or a computer workstation (e.g., an off-the-shelf desktop or laptop) to prepare for the implantation of an orthopaedic prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant. It is used for the implantation of total- or partial-joint prostheses typically of the knee, hip, shoulder, or ankle.Class 1An application software intended to generate 3D computer simulations of patient anatomy from CT images. The subject system is designed to allow surgeons to view the biomechanics of imperfect joint prior to an operation and then use the 3D reconstruction on the software to decide on the exact location of joint replacement implant. The software then automatically constructs a CAD file which is used for 3D printing of a Patient Specific Guide to be used during surgery.
374576TeleMedC Pty LtdTeleMedC Pty LtdAn individual software application program or group of programs used in combination with one or more retinal imaging devices, such as a fundus camera, for either point-of-care or remote (telemedicine) use. The software provides analysis capabilities for the detection of retinopathy and other retinal diseases for early diagnosis and management in patients at risk, to prevent further deterioration and visual loss. A basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. It may also be used in an off-the-shelf desktop, laptop or tablet computer.Class IIaThe DR Grading software is intended to screen and grade Diabetic Retinopathy (DR) in patients/general population through colour fundus retinal images. The DR Grader is indicated for use by health care providers to automatically detect and grade diabetic retinopathy in patients who have been diagnosed with diabetes and screen those who have not yet been diagnosed with diabetes.
380111Mediwhale IncCompliance Management SolutionsAn individual software application program or group of programs used in combination with one or more retinal imaging devices, such as a fundus camera, for either point-of-care or remote (telemedicine) use. The software provides analysis capabilities for the detection of retinopathy and other retinal diseases for early diagnosis and management in patients at risk, to prevent further deterioration and visual loss. A basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. It may also be used in an off-the-shelf desktop, laptop or tablet computer.Class IIaIt is a software based on artificial intelligence that assists medical personnel by inputting the patient's fundus image and indicating the suspected symptoms of eye diseases (cataract, glaucoma, retinal disease) and predicting cardiovascular risk.
380977Medtronic IncMedtronic Australasia Pty LtdAn application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.Class IIbThe intended use of the AccuRhythm AI ECG classification system is to reduce false positive cardiac arrhythmia episodes.
382110EKO AI Pte LtdAA-Med Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIbUs2.v1 is a software platform that automatically processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making based on DICOM images produced by FDA approved ultrasound devices. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi).
387417iCAD IncRegional Health Care Group Pty LtdAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.Class IIb: iCAD ProFound AI for full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) software is a computer-assisted detection and diagnosis (CAD) Artificial Intelligence (AI) software device intended to be used concurrently by physicians while reading FFDM and DBT exams from compatible FFDM and DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the FFDM images and DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting physician.
388612Precision Medical Ventures Inc dba RevealDXEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbThe Software is a clinical decision support, computer aided diagnostic (CADx) software application intended for analysis of computed tomography (CT) scans of the lung. The software compares physician-selected nodules against a clinically established database of lung nodules and provides a similarity score to assist clinicians’ assessment of patients’ cancer risk. The Software is designed to be used by radiologists and other healthcare practitioners who are licensed to make diagnostic or other follow-up decisions using radiological imagery and/or radiology reports. The information provided by the Software should only be used in conjunction with other clinically accepted information to guide medical decision-making at the discretion of the clinician.
396352SIM & CUREEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIaThe Sim&Size software is a medical device intended to provide a 3D view of the final deployment of neurovascular implantable medical devices of type flow diverters, intrasaccular devices, stent devices and coils. It uses an actual image of the patient produced by 3D rotational angiography. It offers physicians the possibility of simulating the deployment of implantable medical devices in the artery to be treated and predicts the final placement and the extent of apposition of the implant. Sim&Size is not intended for diagnostic use or for recommending a specific treatment.
400152CoTreat Pty LtdCoTreat Pty LtdAn application software program intended to facilitate clinical management decisions by receiving structured patient data from electronic health records (e.g., demographics, diagnostic, laboratory results) and returning clinical care information (e.g., reminders, suggestions and links to guidelines) to a healthcare professional responsible for patient care. Otherwise known as clinical decision support (CDS) software, it is implemented as a web service (a program that runs on a web server communicating with other software, and that has no user-interface of its own).Class 1CoTreat is a web based app that aims to help dentists make better clinical decisions when formulating their patient treatment plans. Users upload clinical photos, radiographs to the CoTreat platform. CoTreat then uses this data to make empirical observations (not diagnoses) to help the dentist with their own decision making process. Using a combination of machine learning algorithms and human expertise, the data is analysed and reported back to the dentist with observations on caries, tooth wear, calculus, endodontics, orthodontics, wisdom teeth, restorations and aesthetics. The report can be tallied up across a defined time period to provide insights into the treatment planning behaviours of dentists, to support evidence based decision making
403475Avicenna AIACRA Regulatory Services Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIbCINA is a radiological computer aided triage and notification software indicated for use in the analysis of (1) non-enhanced head CT images and (2) CT angiography of the head.

405621

ScreenPoint Medical B.V.Siemens Healthcare Pty LtdAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbDevice is intended to support healthcare professionals with detection and diagnosis of breast 
lesions or for assessment of breast density and breast cancer risk using radiological images of the 
breast.
406912Lunit IncAA-Med Pty LtdAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIaThe Lunit INSIGHT CXR is a Computer-Assisted Detection (CADe) software device based on an artificial intelligence algorithm intended for use as a concurrent reading aid for interpreting physicians reading chest radiographs, to detect, localize, identify, and characterize suspicious abnormal radiological findings. As an adjunctive tool, the device is intended to be viewed by interpreting physicians and it is not intended as a replacement for a complete clinician’s review or their clinical judgement that considers other relevant information from the image or patient history.
408737Avicenna AIACRA Regulatory Services Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIbCINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiography. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) Chest CT angiography for Pulmonary Embolism (PE) and (2) Chest or Thoraco-abdominal CT angiography for Aortic Dissection (AD). 
CINA CHEST uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) PE or (2) AD on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected PE or AD findings. 
Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. 
The results of CINA CHEST are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
413272Enlitic IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn individual software program, routines or algorithms used as a radiology information system (RIS) for use in diagnostic imaging and/or radiation therapy environments. It supports the clinical and administrative activities of the imaging departments, e.g., scheduling, generation of work lists for individual imaging/therapy systems and is generally used in conjunction with a picture archiving and communications system (PACS), if implemented. Some radiology departments may include nuclear medicine, ultrasound, and other imaging modalities. It is typically for installation into a dedicated radiology information system or existing mainframe or decentralized computers/network.Class 1The Ensight product is software that generates standardized metadata descriptions of medical images. The software also de-identifies PHI in metadata and image pixel data of medical images. The output of this functionality is used for various healthcare workflows such as hanging protocols, billing, and research. Using proprietary natural language processing (NLP) and computer vision (CV) algorithms, it reviews information from DICOM images and metadata to identify key attributes of radiological examinations for standardization, and for detecting and redacting PHI. It contains basic functionality such as user access and security, dashboards for analytics, and allows for integration with other devices such as third-party PACS software.
416201Quibim SLEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn interpretive software program intended to be used to analyse magnetic resonance imaging (MRI) data (e.g., prostate MRI) to detect and localize suspected abnormalities and sometimes provide results as clinically relevant tags; it may additionally be intended for three-dimensional (3-D) model creation slice-based images (segmentation). It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbMedical imaging processing application intended for image processing and analysis of prostate MRI. The application should be used by trained medical professionals, including but not limited to radiologists, urologists, and oncologists. Patient management decisions should not be based solely on the results of this device. The software can be used in combination with a DICOM viewer and segmentation tool that allows for image visualization and user interaction.

427104

Pearl IncPharmaDEV Consulting Pty LtdAn interpretive software program intended to be used to analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localization and classification of teeth, detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants); it utilizes artificial intelligence (AI)/deep learning algorithms.Class IIaSecond Opinion® is a computer aided detection ("CADe") software to identify and mark regions in relation to suspected dental findings which include Caries, Bone Loss, Discrepancy at the margin of an existing restoration, Calculus, Periapical radiolucency, Widened Periodontal Ligament, Crown (metal, including zirconia & non-metal), Filling (metal & non-metal), Root Canal, Bridge and Implants. For pediatric patients (ages 4-11), Second Opinion® is intended only for the detection of caries.
It is designed to aid dental health professionals as a second reader in the review of:
Bitewing and periapical radiographs for patients 4 years and older with primary or permanent teeth (primary or mixed dentition) and are indicated for dental radiographs, and
Bitewing, periapical, and panoramic radiographs of permanent teeth in patients 12 years of age or older.
431462DGNCT LLCTaevas Life Sciences Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines (packages) must be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class 1The Diagnocat AI automated information system is designed for cloud-based storage
and processing of digital dental images using artificial intelligence. Diagnocat AI has
been developed to automate the activities of dental organizations in radiological
examinations, including examination uploading, screening of diagnostic images, saving,
sharing, editing and drawing conclusions.
Diagnocat AI processes files of any area of the patient's maxillofacial region. Diagnocat
AI is designed for use by medical professionals (dentists, orthodontists, radiologists,
etc.) for education purposes and highlights anatomical areas, common conditions, and
previous treatments.
Diagnocat AI automatically produces radiological reports for easier viewing and
documentation of investigation for a particular patient. Diagnocat AI can also be used by
managers and administrators of clinics to document patient treatment history and
maintain personal records.
This is a reusable, non-invasive device for image processing and documentation. The
Software cannot be used to make a decision about the diagnosis, presence or absence
of a disease on the basis of the online screening, without additional investigation.
The Software cannot be used for direct diagnosis and clinical decision making.
431535Mvision AI OyAA-Med Pty LtdAn application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number.Class IIbContour+ (MVision AI Segmentation) is a software system for image analysis algorithms to be used in radiation therapy treatment planning workflows. The system includes processing tools for automatic contouring of CT and MR images using machine learning based algorithms. 
The produced segmentation templates for regions of interest must be transferred to appropriate image visualization systems as an initial template for a medical professional to visualize, review, modify and approve prior to further use in clinical workflows.
The system creates initial contours of pre-defined structures of common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis. 
Contour+ (MVision AI Segmentation) is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.
450309Shenzhen Viatom Technology Co LtdShare Info Pty LtdA battery-powered wearable device, typically in the form of a wristband, designed to continuously measure and record multiple physiological parameters (e.g., heart rate, respiration rate) and movement, during normal day- and night-time activities at home. It includes an optical sensor to capture a photoplethysmogram (PPG), and an accelerometer to capture movement. The data is typically transferred to a local application or central database for analysis which includes evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).Class IIaThe product is intended to measure, review and store adults’ ECG data at home or in healthcare environment, does not contain an auto-analysis function.
The ECG recorder is intended to record, display, store and transfer single-channel electrocardiogram(ECG) rhythms at home or in healthcare environment. The device does no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system (AI-ECG Tracker) which will analyze the recorded data. The device data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The device is intended for use by adults’ health-conscious individuals. The product does not include analysis and diagnosis functions. The product has not been tested and it is not intended for pediatric use.
450388Shenzhen Viatom Technology Co LtdShare Info Pty LtdA device for 24-hourly registration of a patient's heart activity, which is connected to, and carried by the patient during the period of recording. The signals are stored, e.g. on a cassette (magnetic tape), or a digital medium (no moving parts). The recording is analysed at the hospital using an Electrocardiograph, Holter analyser, or a computer, see: Computer, <specify>, together with dedicated software.Class IIaThe Wireless dynamic multi-parameter holter is a small digital ambulatory ECG recorder. It is intended to record, store, display, transfer ECG data, receive and display blood oxygen (SpO2) and PR (pulse rate) data from the Pulse oximeter (SpO2 Probe); For routine checkups and/or self-monitoring of patients in the clinical setting and/or home settings under professional (e.g. doctor, nurse, family doctor) supervision. 
Clinical setting is only applicable to the general medical clinical setting, not for ICU, Emergency, Intensive care, Surgery, and the clinical setting that must be specifically alarmed and analyzed.
The Wireless dynamic multi-parameter holter does not include analysis and diagnosis functions, does not include monitoring function. Data are given to the doctor or the user. The device no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system (AI-ECG Tracker) which will analyze the recorded data. The device data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis.
The device data are used as a base to establish a doctors' diagnosis, but the data cannot replace the diagnosis result given by a doctor.
450406Shenzhen Viatom Technology Co LtdShare Info Pty LtdAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.Class IIaThe Blood pressure monitor is intended to record, store, display and transfer single-channel electrocardiogram (ECG), blood pressure and pulse rate in adult population.
The device does no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system (AI-ECG Tracker) which will analyze the recorded data (used under the care of a physician). The device data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis.
The device is intended for use by adults’ health-conscious individuals.
The device does not include analysis and diagnosis functions.
The device has not been tested and it is not intended for pediatric use.
450425Shenzhen Viatom Technology Co LtdShare Info Pty LtdA device for 24-hourly registration of a patient's heart activity, which is connected to, and carried by the patient during the period of recording. The signals are stored, e.g. on a cassette (magnetic tape), or a digital medium (no moving parts). The recording is analysed at the hospital using an Electrocardiograph, Holter analyser, or a computer, see: Computer, <specify>, together with dedicated software.Class IIaThe Dynamic ECG recorder is intended to measure, review and store adults’ECG data at home or in healthcare environment. 
The device continuously records and stores ECG and activity data for at least 7 days at a time. The device does no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system (AI-ECG Tracker) which will analyze the recorded data. The device data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. 
The device does not include analysis and diagnosis functions. The device has not been tested and it is not intended for pediatric use.
454945Harrison-AI Medical Pty LtdHarrison-AI Medical Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class 1The device is an accessory that is intended to interface with x-ray image interpretive software.
459645Ibex Medical Analytics LtdTaevas Life Sciences Pty LtdAn interpretative software algorithm intended to be applied to a clinical result or set of results obtained through testing in order to identify and/or formulate additional clinical information which may then be used to guide patient management.Class 3The Ibex platform is a software only device intended for supporting the pathologist in interpreting whole slide images (WSIs) of digitized glass slides originating from H&E stained histological glass slides. The application is designed to assist in normal pathology laboratory workflow as a first read, as a means to support the pathologist in the review of the slides, aiding in viewing and managing WSIs of stained histology specimens, identifying suspected findings and providing characterization, such as tissue classification and slide and/or case-level categorization of cancer likelihood and grade. The application results are not intended to be used as a standalone basis for a pathology report or diagnosis, nor are they intended to rule out cancer or otherwise preclude pathological assessment of WSIs.
The Ibex platform includes solutions for prostate, breast, and gastric tissues, each with offerings for the following Indications for Use:
Ibex Prostate is indicated for hematoxylin and eosin (H&E) stained adult prostate core needle biopsy (PCNB) specimens. The application provides tissue classification and slide-level categorization of cancer associated with prostate biopsies likelihood and grade.
Ibex Breast is indicated for hematoxylin and eosin (H&E) stained adult women breast biopsy or excision specimens. The application provides tissue classification and case-level categorization of cancer associated with breast biopsies or excision specimens likelihood and grade.
Ibex Gastric is indicated for hematoxylin and eosin (H&E) and hematoxylin-eosin-saffron (HES) stained adult gastric biopsy specimens. The application provides tissue classification and case-level categorization of cancer likelihood and grade, and key suspicious findings associated with gastric biopsies.
459908Aidoc Medical LtdACRA Regulatory Services Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class 1Medical Image AI operating system intended to be used to route radiological studies for processing by Medical Image Processing AI Solution Devices, and to provide image and results review software functionality
462546CurveBeam LLC DBA CurveBeam AICurveBeam AI LimitedA diagnostic x-ray computed tomography (CT) system having a gantry whose design limits its use to head and neck and/or extremity imaging applications. Included are single or multiple fixed annular arrays of x-ray tubes and opposing detectors or x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce 2 and/or 3-dimensional cross-sectional (tomographic) images, including spiral CT or other imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.Class IIbThe HiRise is intended to be used for 3‐D imaging of the upper and the lower extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs.
The device is to be operated in a professional healthcare environment by qualified health care professionals only.
463707OASIS Diagnostics S AMurray Medical Solutions Pty LtdAn invasive, hand-held device designed to be used with an electrical impedance spectrometer to detect postpartum obstetric anal sphincter injuries (OASIs) by applying low-voltage electrical signals inside the anal canal via electrodes on the distal end of the device. This is a single-use device.Class IIaThe ONIRY Probe, along with the ONIRY Spectrometer, is intended for rapid detection of obstetric anal sphincter injuries in postpartum period utilizing machine learning-assisted impedance spectroscopy method. The probe is a disposable device that works with the ONIRY Spectrometer. The product is intended for use only by health professionals within the environment of specialist medical care. Patient target group is women in the postpartum period following vaginal delivery.

470185

AZmedTaevas Life Sciences Pty LtdAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIaRayvolve is designed to help radiologists and emergency physicians to detect and localize medical abnormalities standard X-rays.
Rayvolve helps detect: 
● Fractures on osteoarticular X-rays of the following organs: hand, wrist, forearm, elbow, arm, shoulder, foot, ankle, leg, knee, and femur. 
● Bone measures' abnormalities (angle/length) on lower limb (including hip, knees, foot) and spine. 
● Bones characterisation for bone age abnormalities estimation on hand. 
Rayvolve can analyze X-rays of adult and pediatric patients.
The radiographs analyzed are: Computed Radiography (CR), Radio Fluoroscopy (RF) et Digital Radiography (DX).
Rayvolve is indicated for adults and the pediatric population.
472005CurveBeam LLC DBA CurveBeam AICurveBeam AI LimitedA diagnostic x-ray computed tomography (CT) system having a gantry whose design limits its use to head and neck and/or extremity imaging applications. Included are single or multiple fixed annular arrays of x-ray tubes and opposing detectors or x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce 2 and/or 3-dimensional cross-sectional (tomographic) images, including spiral CT or other imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.Class IIbThe InReach is intended to be used for 3-D imaging of the hand, wrist, elbow, knee, foot, and
ankle regions, to visualize and assess the osseous and certain soft tissue structures, including
joint spaces, bone angles and fractures. This modality is anticipated to be applicable to
pediatric* cases as well as adults*, when appropriate diagnosis of a given hand, wrist, elbow,
knee, foot or ankle condition is considered necessary.
* Patient parameters: 50lbs to 400lbs
475785Lenexa Medical Pty LtdLenexa Medical Pty LtdAn evaluative system, intended for medical purposes, used to measure the actual pressure between an anatomical body surface and a supporting media. Typically using an array of pressure sensors this system will provide a map of applied pressure between, e.g. a seating cushion and the anatomical shape of the patient. This system is typically used to customize the shape of seating cushions to alleviate the possibility of pressure sores developing from long-term use of the cushion, such as in wheelchair seating customization.Class 1The LMPIMS platform is indicated for use by clinicians and caregivers for ongoing monitoring of patient positioning data for patients in medical beds using static foam mattresses. The device provides information with respect to what position the patient is resting in and for how long they have been in such positions. Clinicians and caregivers in healthcare facilities will be able to use this information as an aid  in delivering prompt pressure area care, helping to reduce the risk of developing pressure injuries.
481005DGNCT LLCTaevas Life Sciences Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines (packages) must be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaThe Diagnocat AIS automated information system is designed for cloud-based storage
and processing of digital dental images using artificial intelligence. Diagnocat AIS has
been developed to automate the activities of dental organizations in radiological
examinations, including examination uploading, screening of diagnostic images, saving,
sharing, editing and drawing conclusions. Diagnocat AIS processes files of any area of
the patient's maxillofacial region. Diagnocat AIS is designed for use by medical
professionals (dentists, orthodontists, radiologists, etc.) for education purposes and
highlights anatomical areas, common conditions and previous treatments.
DiagnocatAIS automatically produces radiological reports for easier viewing and
documentation of investigation for a particular patient. Diagnocat AIS can also be used
by managers and administrators of clinics to document patient treatment history and
maintain personal records. This is a reusable, non-invasive device for image processing
and documentation. The Software cannot be used to make a decision about the
diagnosis, presence or absence of a disease on the basis of the online screening,
without additional investigation.
The Software cannot be used for direct diagnosis and clinical decision making.
481248Formus Labs LimitedFormus Labs Australia Pty LtdAn individual software application program intended to add specific computer-assisted display, processing, and/or analysis capabilities to a computer and/or a computer workstation (e.g., an off-the-shelf desktop or laptop) to prepare for the implantation of an orthopaedic prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant. It is used for the implantation of total- or partial-joint prostheses typically of the knee, hip, shoulder, or ankle.Class IIaFormus Hip is a software product of the Formus Platform intended to provide orthopaedic surgeons or other trained healthcare professionals information about the fit of orthopaedic implants for primary total hip arthroplasty (THA). The software is intended to read in and interpret pre-dimensioned computerized tomography (CT) scans, simulate the fit of an in-built library of orthopaedic implants to the patient anatomy in the scans, and display information about the fit of each implant to the user in a graphical user interface and a printable report. The software is intended to be used on the scans of patients indicating a need for primary THA.
481927MIM Software IncNL-Tec Pty LtdAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to picture archiving and communication system (PACS) used for radiology. A basic set of applications programs and routines are included with such a PACS and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaContour ProtégéAI is an accessory to MIM software. It includes processing components to allow the
contouring of anatomical structures using machine-learning-based algorithms automatically.
Appropriate image visualization software must be used to review and, if necessary, edit results
automatically generated by Contour ProtégéAI.
Contour ProtégéAI is not intended to detect or contour lesions.
483045MIM Fertility Sp zo oGytech Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class 1AI powered follicular monitoring. used to identify, calculate and measure follicles of all sizes in a 2-second 2D or 3D cine loop of the ovary, conducted via a transvaginal ultrasound.
483070MIM Fertility Sp zo oGytech Pty LtdAn application software program intended to be used as part of an embryo-assessment microscope camera system to store, and allow comparison/evaluation of, acquired embryo images, to assist embryo selection during assisted reproduction/in vitro fertilization (IVF). Typically it allows the user to analyse still images and videos of embryonic growth, to annotate or categorize images, and to store patient medical records. It is intended to be used by healthcare professionals in a clinical setting.Class 1Embryoaid is a software application Based on AI, designed to support embryologists in the process of embryo assessment during IVF treatment. By examining the user uploaded data ( images or videos ), the application presents a classification corresponding to the developmental potential of embryos prior to the transfer procedure.
483245Neusoft Medical Systems Co LtdStonestar Wholesale Pty LtdA diagnostic x-ray computed tomography (CT) system with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce 2 and/or 3-dimensional cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.Class IIbThe NeuViz ACE 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating Xray tube and detector array. The acquired XRAY transmission data is reconstructed by computer into cross-sectional images of the body from either
the same axial plane taken at different angles or spiral planes taken at different angles. It is used to scan the patient (neonate, child and adult) and perform post image processing for diagnoses of the patient.
483608EM2Ai Pte LtdVassallo Consulting TrustAn interpretive software program intended to be used to analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localization and classification of teeth, detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants); it utilizes artificial intelligence (AI)/deep learning algorithms.Class 1The EM2Clinic Software is a reusable, non-invasive tool intended to be used by medical professionals (dentists, radiologists, etc) to assist them in interpreting and documenting digital dental images. The software uses artificial intelligence (AI) to highlight anatomical areas, common conditions and possible abnormalities, as well as past dental procedures or treatments. The software will automatically generate dental charting of the highlighted area to enhance visualisation and is able to produce reports for documentation of investigation of a particular patient. This software is not intended for direct diagnosis or clinical decision-making. It cannot be used to determine the presence or absence of disease, based on the AI analysis only, without further evaluation by a qualified healthcare professional. The software can suggest possible treatments or interventions to a relevant healthcare professional to support their decision-making process, but will not replace the healthcare professionals’ judgement. The healthcare professional remains responsible for determining the patient's treatment plan.
48455916 Bit IncLC & Partners Pty LtdAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIaRho is an opportunistic screening tool that analyzes frontal radiographs of the lumbar
spine, thoracic spine, chest, pelvis, knee, or hand performed for any clinical indication in
patients aged 50 years and older. The algorithm was developed using machine learning to
generate a risk score that correlates with a patient's likelihood of having low bone mineral
density.
485067Philips France CommercialEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] and/or include the ability to record images and movies.Class IIbThe Cardiologs Holter Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population. The Cardiologs Resting Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias and structural abnormalities using ECG data in subjects over 18 years of age. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices for the assessment the heart rhythm. The Cardiologs Holter Platform and Cardiologs Resting Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. The Cardiologs Holter Platform and Cardiologs Resting Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement and rhythm analysis. The Cardiologs Holter Platform and Cardiologs Resting Platform are not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
Cardiologs Holter Platform and Cardiologs Resting Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
485245EKO AI Pte LtdAA-Med Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIbUs2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyse and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers and radiologists to generate a report for review and approval by a qualified cardiologist with echocardiography subspecialty certification. Any generated report should not be used for clinical decision making before such review and approval. Us2.v2 is indicated for use in adult patients.
486091Tecan Schweiz AGEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaManual, semi-automated or automated equipment or apparatus that are intended by the manufacturer to be used as an in vitro diagnostic medical device (IVD) for the purposes of processing, examining and/or providing information about a clinical specimen.Class 1The instrument is an automated laboratory liquid handling platform for in vitro diagnostic use. The product is intended for the automation of clinical sample preparation and processing of clinical diagnostic assays using human specimens. The type of specimen and specific diagnostic protocol is defined and validated by the user for their selected clinical assay. The product is intended for healthcare professionals and professional laboratory use by trained personnel. The product is not intended for self-testing or near patient testing.
487585Limbus AI IncTaevas Life Sciences Pty LtdAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.Class IIbLimbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning.
Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios:
● Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning.
● Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy
and archiving contours for patient follow-up.
● Localization and definition of healthy anatomical structures.
Limbus Contour is not intended for use with digital mammography.
488141INHEART SASEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to picture archiving and communication system (PACS) used for radiology. A basic set of applications programs and routines are included with such a PACS and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class 1inHEART Portal is an accessory of the following medical devices: inHEART Models Explorer and inHEART Models AI. It is a secured web platform for the management of customers’ orders and the transfer of data between inHEART and its customers.
It allows customers to place and track orders, as well as to access online inHEART Models Explorer and to launch inHEART Models AI.
This web platform is intended to be used by qualified health professionals (including physicians, cardiologists, radiologists, and technicians) and inHEART staff (including Imaging analysts, sales representatives and Admins).
Preoperatively, it is intended to be used to assist with the planning of the procedure.
Intraoperatively, it is intended to be used to assist with the catheter navigation and with the identification of the arrhythmogenic substrate. Clinicians are solely responsible for making all final patient management decisions.
488425ClariPi IncJY Medical Solutions Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIbClariCT.AI software is intended for de-noise processing and enhancement of CT DICOM images when higher image quality and/or lower dose acquisitions are desired.The ACE module is an optional module that additionally improves the CNR of CECT(Contrast-Enhanced CT)images. The PET-SPECT module is an optional module for denoise processing and enhancement of PET or SPECT fusion CT images that is expressed as 16-bit DICOM secondary capture format.
488986GE Medical Systems Ultrasound and Primary Care Diagnostics LLCGE Healthcare Australia Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaVenue Sprint is a software component that, when installed on a compatible Windows device and used together with the Vscan Air CL and Vscan Air SL probes, serves as a general-purpose diagnostic ultrasound system for ultrasound imaging, measurement, display and analysis of the human body and fluid.
489067OASIS Diagnostics S AMurray Medical Solutions Pty LtdAn electrically-powered instrument designed to detect postpartum obstetric anal sphincter injuries (OASIs) using real-time electrical impedance (bioimpedance) spectroscopy [EIS/BIS]. It is used in conjunction with an obstetrical/gynaecological anal probe (not included), and incorporates a visual interface and machine-learning software designed to produce a diagnostic result (e.g., injury or no injury) for clinical decision support.Class IIaThe ONIRY Spectrometer, along with the ONIRY probe, is intended for rapid detection of obstetric anal sphincter injuries in postpartum period utilizing machine learning-assisted impedance spectroscopy method. The product is intended for use only by health professionals within the environment of specialist medical care. Patient target group is women in the postpartum period following vaginal delivery.
489245Manteia Technologies Co LtdOxford Scientific Pty LtdAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.Class IIbMOZi Treatment Planning System (MOZi TPS) - is used to plan radiotherapy treatments for patients with malignant or benign diseases. MOZi TPS is used to plan external beam irradiation with photon beams.
489327GE Medical Systems Ultrasound and Primary Care Diagnostics LLCGE Healthcare Australia Pty LtdA general-purpose diagnostic ultrasound imaging system designed exclusively for use in a wide variety of both extracorporeal and/or intracorporeal (endosonography or endoscopic) body imaging procedures. A general-purpose system supports a wide variety of transducers and related application software packages allowing for the collection, display and analysis of ultrasound information. Usages are, e.g. general-purpose imaging, cardiac, OB/GYN, endoscopy, breast, prostate, vascular, intra-surgical, Doppler or colour Doppler, depending on the operating system specific software packages and compatible ultrasound transducers.Class IIaThis is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The ultrasound system is intended to be used in a hospital or medical clinic.
489345Materialise NVAA-Med Pty LtdA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.Class IIaThe subject devices are intended to be used for simulation and the planning of medical procedures. 
The subject devices can be used to assist in the positioning of medical device components and to evaluate their size and delivery. The output can be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The fabricated output can be used for diagnostic purposes in the field of orthopedic applications. 
The subject devices should be used in conjunction with other diagnostic tools and expert clinical judgement.
489425Nobel Biocare ABNobel Biocare Australia Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIbA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; to support the diagnostic process and treatment planning for dental and craniomaxillofacial procedures.
489427Align Technology IncInvisalign Australia Pty LtdAn interpretive software program intended to be used to analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localization and classification of teeth, detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants); it utilizes artificial intelligence (AI)/deep learning algorithms.Class IIaAlign X-ray Insights is a computer aided detection ("CADe”) software product that aids dental practitioners in the detection and analysis of dental radiographic image data for dental conditions for permanent dentition. The product is used in a professional dental practice environment by dental practitioners. Align X-ray Insights analyzes bitewing, periapical, and panoramic radiographs using a set of artificial intelligence (AI)-based algorithms to assist in the detection of suspected radiographic abnormalities (caries, periapical radiolucencies, periodontal bone loss, and dental calculus), and other radiographic findings (dental fillings, dental crowns, dental implants, dental bridges, root-canal fillings, proximity of lower molars to mandibular canal, and impacted teeth). The classification and segmentation of teeth is used for tooth charting and reporting.
The results of Align X-ray Insights are intended to be used in conjunction with evaluation of other patient and clinical information including examination of radiographs as determined by the dentist’s clinical standard of care and should not be solely relied upon to make or confirm a diagnosis.
489477Samsung Electronics Co LtdSamsung Electronics Australia Pty LtdAn Internet-based software program intended to be used by a patient in a non-clinical environment to provide general health assessment information and/or health advice through an interactive platform. The software is intended to collect patient information (demographics, lifestyle data, and/or symptoms) and feedback information to indicate the general health/wellness in key areas (e.g., mental, cardiovascular) and/or assist the patient in deciding the best course of action if they are unwell (e.g., see a clinician, self-treatment for minor ailments). It does not communicate with a clinician.Class IIaThe Sleep apnea feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate-to-severe obstructive sleep apnea in the form of significant breathing disruptions over a two-night monitoring period, for adult users 22 years or older. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
489553Mazor Robotics LtdMedtronic Australasia Pty LtdAn assembly of devices that may consist of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline (e.g., orthopaedic and ENT). The system may include computerized functions to store diagnostic images used for image-guided surgery.Class IIbFor precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in either open or minimally invasive or percutaneous procedures.
490186Zetta 25 AGDentsply Sirona Pty LtdAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to picture archiving and communication system (PACS) used for radiology. A basic set of applications programs and routines are included with such a PACS and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaDS Core CBCT Anatomy supports the viewing and analysing of X-ray images for the product DS Core Diagnosis by the detection of anatomical structures on 3D X-ray scans.
DS Core CBCT Anatomy constitutes supporting backend functionalities for the product DS Core Diagnosis.
490605HeartLab LtdEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to picture archiving and communication system (PACS) used for radiology. A basic set of applications programs and routines are included with such a PACS and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaIntended to facilitate transfer, storage, retrieval, archival, review, analysis, quantification, and management of digital images and patient information, including study annotation and patient reporting. Not intended for acquiring medical images or signals directly from patients.
490788GE Medical Systems Ultrasound and Primary Care Diagnostics LLCGE Healthcare Australia Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaThis software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The software is an accessory to compatible general purpose diagnostic ultrasound systems. The software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients. 
The EF feature is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.
491069CARPL.AI IncResper Solutions Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class 1CARPL is a web-based PACS and radiology workflow management device, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D/3D mammography. It gathers digital images and information from a variety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF machines, PET units, secondary capture tools, imaging gateways. CARPL enables storage, transmission, processing, and visualization of images and data within the system itself or over computer networks spanning different locations.
CARPL offers the choice to incorporate third-party AI models that have been approved by the regulatory authority. CARPL solely aids in visualizing the outcomes of these third-party AI models without modifications. The safety and efficacy of the third-party models are governed by the regulatory approval granted to the original manufacturer of the said model. CARPL simply presents the simple AI response output, and the initial anonymized image remains consistently available. 
This system is designed exclusively for use by proficient and certified medical experts, including physicians, radiologists, and medical technicians.
492325RetInSight GmbHEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn individual software application program or group of programs used in combination with one or more retinal imaging devices, such as a fundus camera, for either point-of-care or remote (telemedicine) use. The software provides analysis capabilities for the detection of retinopathy and other retinal diseases for early diagnosis and management in patients at risk, to prevent further deterioration and visual loss. A basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. It may also be used in an off-the-shelf desktop, laptop or tablet computer.Class IIaThe RetInSight GA Monitor is a medical device for professional use only, intended to quantify the lesions of the pathological integrity loss areas in the retina (i.e. Retinal Pigment Epithelium (RPE) Loss and Photoreceptor (PR) Degeneration) to support therapeutic decisions in the management of Geographic Atrophy (GA) in AMD. Results from the RetInSight GA Monitor should not be the sole basis for a patient diagnosis or therapeutic decisions. Results generated by the RetInSight GA Monitor should be considered along with the assessment of the patient´s history and the current clinical condition of the patient and the affected eye.
492566CurveBeam LLC DBA CurveBeam AICurveBeam AI LimitedA diagnostic x-ray computed tomography (CT) system having a gantry whose design limits its use to head and neck and/or extremity imaging applications. Included are single or multiple fixed annular arrays of x-ray tubes and opposing detectors or x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce 2 and/or 3-dimensional cross-sectional (tomographic) images, including spiral CT or other imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.Class IIbThe LineUP is intended to be used for 3-D imaging of the foot, knee, hand, and elbow regions to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures.
It is also intended to capture 2-D images (standard plain x-ray projections) of the foot, knee, hand, and elbow regions.
This modality is anticipated to be applicable to pediatric* cases as well as adults, when appropriate diagnosis of a given condition is considered necessary. Patient parameters: 50 lbs to 400 lbs 
*2D Imaging not intended for pediatric use.
492605Manteia Technologies Co LtdOxford Scientific Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIbAccuContour - A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
493747WithingsEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaA mains electricity (AC-powered) device assembly, sometimes with a rechargeable battery, designed to electronically measure and display multiple patient physiological parameters [e.g., blood pressure, blood glucose, pulse rate, temperature, haemoglobin oxygen saturation (SpO2), and possibly calculate mean arterial pressure (MAP)] for intermittent spot-check measuring in the home. It typically includes a main analysis unit with a visual display, and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, blood glucose meter) or external devices (e.g., USB cable). It may be used in a healthcare facility or in the home.Class IIaThe device is a non-sterile, contactless, reusable clinical thermometer intended for the intermittent determination of human body temperature over the temporal artery as the measurement site on people of all ages. 
The device is also an electronic stethoscope that enables the recording and transmission of heart and lung auscultation sound data. The device is intended to be used by professional users in a clinical environment or by lay users in a non-clinical environment on people of all ages.
The device measures, transfers, records, and displays lead I of an ECG. It calculates the heart rate and detects the presence of atrial fibrillation or sinus rhythm on a classifiable ECG waveform. 
The device is also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (blood oxygen, or SpO2) and pulse rate (PR). It is indicated for use with individuals 18 years and older. 
The companion app allows the device installation and displays the results of performed measurements.
493926Mojo Tech HoldingsMojo Tech HoldingsAn assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement (e.g., reaching, grasping, balance); it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, movement tracking camera, software) that communicate wirelessly to provide a virtual-display interface.Class 1The Mojo device is a software-based medical device intended for use in musculoskeletal rehabilitation. It enables patients, and their treating clinicians, to monitor and track progress in structured exercise and strengthening programs. The device measures movement, self-assessed patient pain and progress and other metrics to support understanding of rehabilitation progress. Mojo is used under clinical supervision and we see this as important tool in the treatment on musculoskeletal disease. 
493929WithingsEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaA battery-powered wearable device, typically in the form of a wristband, designed to continuously measure and record multiple physiological parameters (e.g., heart rate, respiration rate) and movement, during normal day- and night-time activities at home. It includes an optical sensor to capture a photoplethysmogram (PPG), and an accelerometer to capture movement. The data is typically transferred to a local application or central database for analysis which includes evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).Class IIaThe device is a medical device composed of software and the dedicated hardware of a reusable wrist applied device, which incorporates a single-lead electrocardiograph (ECG) and a reflectance photoplethysmograph (PPG). It is intended for intermittent measurements.
The device measures, transfers, records, and displays lead I of an ECG. It calculates the heart rate and detects the presence of AF or sinus rhythm on a classifiable ECG waveform.
The device measures, transfers, records and displays pulse rate to identify episodes of irregular heart rhythm suggestive of AF and provides a notification to the user. It can be used to supplement a clinician’s decision to screen for possible AF.
The device is indicated for over-the-counter (OTC) use in adults.
The device is not recommended for users with other known arrhythmias.
The companion app allows the device installation and displays the results of performed measurements.
499711Shenzhen Angell Technology Co LtdGamma Gurus Pty LtdA stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.Class IIbFor use in generating radiographic and fluoroscopic images of human anatomy in all general purpose X-ray diagnostic procedure.
502306Proprio IncLife Healthcare Pty LtdA mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/localizers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].Class IIaThe system is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified from CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae
504728Whoop IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaA portable electronic instrument designed to be used by a layperson in the home, or by medical personnel in a clinical setting, to measure electrical potentials on the body surface to produce a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple-electrode sets (leads) [may be included] simultaneously, and includes software for interpretation/analysis of the record. It may be an independent device or designed to be connected to a computer, and typically provides a print-out ECG.Class IIaThe WHOOP ECG feature is intended to determine the presence of atrial fibrillation (AFib), normal sinus rhythm, low heart rate (less than or equal to 50 beats per minute [bpm]), and high heart rate (greater than or equal to 100 bpm) on a classifiable waveform. This is intended for people aged 22 years and over.
504845Whoop IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn application software program designed as an Internet-based information system to collect and aggregate a patient's self-care data for provision of a communication channel between the patient and a healthcare professional, to facilitate a patient's self-care by using rules defined during the use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional and/or exercising information, which may include medication administration information captured from enabled injection devices, and to provide care plan, journal, medication advice, and/or messaging functionalities.Class IIaThe WHOOP Irregular Heart Rhythm Notifications software is intended to opportunistically display a notification of possible AFib when sufficient data is available for analysis. The software is not recommended for users with known atrial fibrillation and is intended for home use by lay people aged 22 years and over.
504906Medacta International SAMedacta Australia Pty LtdAn individual software application program intended to add specific computer-assisted display, processing, and/or analysis capabilities to a computer and/or a computer workstation (e.g., an off-the-shelf desktop or laptop) to prepare for the implantation of an orthopaedic prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant. It is used for the implantation of total- or partial-joint prostheses typically of the knee, hip, shoulder, or ankle.Class IIaThe MyShoulder Planner software is intended for the processing of CT scan images and preoperative planning of the humeral and glenoid components of a total shoulder replacement in skeletally mature individuals who are candidates to receive a Medacta Shoulder System prosthesis.
The MyShoulder Planner software allows for taking preliminary decisions on implant size and positioning for a total shoulder replacement. The MyShoulder Planner software leads to the generation of one or more planning reports for each case.
506501Future Fertility IncMedEnvoy Global Pty LtdAn application software program intended to be used as part of an embryo-assessment microscope camera system to store, and allow comparison/evaluation of, acquired embryo images, to assist embryo selection during assisted reproduction/in vitro fertilization (IVF). Typically it allows the user to analyse still images and videos of embryonic growth, to annotate or categorize images, and to store patient medical records. It is intended to be used by healthcare professionals in a clinical setting.Class 1The intended use of Future Fertility Oocyte Software is to evaluate oocyte quality, from a 2D digital image, by predicting blastocyst formation for patients undergoing ART services. 
This product provides personalized prognostic information on oocyte quality to supplement the standard of care.
506778MIM Software IncGE Healthcare Australia Pty LtdAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to picture archiving and communication system (PACS) used for radiology. A basic set of applications programs and routines are included with such a PACS and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaContour ProtégéAI is an accessory to MIM software. It includes processing components to allow the
contouring of anatomical structures using machine-learning-based algorithms automatically.
Appropriate image visualization software must be used to review and, if necessary, edit results
automatically generated by Contour ProtégéAI.
Contour ProtégéAI is not intended to detect or contour lesions.
507025Eodyne Systems SLAusmedic Australia Pty LtdAn assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement (e.g., reaching, grasping, balance); it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, movement tracking camera, software) that communicate wirelessly to provide a virtual-display interface.Class 1A Rehabilitation Gaming System designed for rehabilitation of functional deficits due to brain damage. It provides individualized training based on virtual reality for the rehabilitation of the patients helping them to optimally regain function and well-being.
508045RetInSight GmbHEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn individual software application program or group of programs used in combination with one or more retinal imaging devices, such as a fundus camera, for either point-of-care or remote (telemedicine) use. The software provides analysis capabilities for the detection of retinopathy and other retinal diseases for early diagnosis and management in patients at risk, to prevent further deterioration and visual loss. A basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. It may also be used in an off-the-shelf desktop, laptop or tablet computer.Class IIbThe RetInSight Fluid Monitor is a medical device for professional use only, intended to quantify the volumes of pathological fluids in the retina, i.e. intraretinal fluid (IRF), subretinal fluid (SRF) and pigment epithelial detachments (PED), to support therapeutic decisions in the management of nAMD. Results from the RetInSight Fluid Monitor should not be the sole basis for a patient diagnosis or therapeutic decisions. Results generated by the RetInSight Fluid Monitor should be considered along with the assessment of the patient´s history and the current clinical condition of the patient.
508105Ortoma ABEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn individual software application program intended to add specific computer-assisted display, processing, and/or analysis capabilities to a computer and/or a computer workstation (e.g., an off-the-shelf desktop or laptop) to prepare for the implantation of an orthopaedic prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant. It is used for the implantation of total- or partial-joint prostheses typically of the knee, hip, shoulder, or ankle.Class IIaThe device enables collecting, structuring and storing data (Medical Imaging Data), to facilitate joint surgical intervention, pre-, peri- and postoperatively. The data can be used for planning and evaluating orthopedic hip surgical procedures in a 3D environment based on medical imaging data of the patient anatomy.
508405Convergent Imaging Solutions IncCompliance Management SolutionsAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIaUniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined
regions on the image.
For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
508407Avicenna AIACRA Regulatory Services Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIbCINA-ASPECTS is a computer-aided diagnosis software device used to assist clinicians, including stroke physicians and radiologists, in the assessment and characterization of brain tissue abnormalities using CT image data.
The Software automatically reorients images, segments and analyzes ASPECTS Regions of lnterest (ROIs). 
CINA-ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into an ASPECT (Alberta Stroke Program Early CT) Score.
CINA-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic (acute) brain tissue injury during image interpretation.
CINA-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring.
508626AliveCor IncAlive Technologies Pty LtdA portable electronic instrument designed to be used by a layperson in the home, or by medical personnel in a clinical setting, to measure electrical potentials on the body surface to produce a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple-electrode sets (leads) [may be included] simultaneously, and includes software for interpretation/analysis of the record. It may be an independent device or designed to be connected to a computer, and typically provides a print-out ECG.Class IIaThe KardiaMobile Card System is intended to record, store and transfer single-channel
electrocardiogram (ECG) rhythms. The KardiaMobile Card System also displays ECG rhythms and output
of ECG analysis from AliveCor’s KardiaAI platform including detecting the presence of normal sinus
rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The KardiaMobile Card System is
intended for use by healthcare professionals, patients with known or suspected heart conditions and
health-conscious individuals. The device has not been tested and is not intended for pediatric use.
509130MyCardium AI LtdMedEnvoy Global Pty LtdAn interpretive software program intended to be used to analyse magnetic resonance imaging (MRI) data (e.g., prostate MRI) to detect and localize suspected abnormalities and sometimes provide results as clinically relevant tags; it may additionally be intended for three-dimensional (3-D) model creation slice-based images (segmentation). It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIb1CMR Pro Software as a Medical Device (SaMD) displays, analyses and transfers DICOM cardiovascular images acquired in Cardiovascular Magnetic Resonance (CMR) scanners, specifically structure, function and flow in the heart and major vessels using multi-slice, multiphase, multi-parametric and velocity encoded CMR images. It is compatible with 1.5T and 3T CMR acquisitions.
509392Mvision AI OyRQSolutions Medical Devices Distribution SupportAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.Class IIbThe device is a software-only medical device and intended for male patients with localized prostate cancer or prostate cancer with pelvic lymph node involvement who are undergoing external beam radiation therapy treatment.The software uses machine learning-based algorithms to automatically produce 3D dose distributions from patient-specific anatomical geometry and target dose prescription.The device is not intended to be used for disease diagnosis and treatment decision  purposes in clinical workflows.
509758Riverain Technologies IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbClearRead Xray Bone Suppress provides improved visibility to the lung parenchyma by suppressing normal bone structures (ribs and clavicles).
ClearRead Xray Detect identifies and marks regions of interest (ROIs) that include suspected solitary pulmonary nodules.
ClearRead Xray Compare highlights differences between a current and a prior chest radiograph, improving the visibility of suspected lung nodules.
ClearRead Xray Pneumothorax (PTX) identifies images with features suggestive of a pneumothorax, for prioritization/triage.
510068Brainlab SEBrainlab Australia Pty LtdA mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/localizers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].Class IIbAutomatic Registration is a software device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images.
510070Brainlab SEBrainlab Australia Pty LtdA mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/localizers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].Class IIbThe Cranial Navigation, when used with a compatible navigation platform and compatible instrument accessories, is intended as image-guided planning and navigation system to enable navigated surgery.
It links instruments to a virtual computer image space on patient image data being processed by the navigation platform.
510125Brainlab SEBrainlab Australia Pty LtdA mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/localizers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].Class IIbAlignment Software Cranial is intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.
510585CenterVue SpaiCare World Australia Pty LtdAn individual software application program or group of programs used in combination with one or more retinal imaging devices, such as a fundus camera, for either point-of-care or remote (telemedicine) use. The software provides analysis capabilities for the detection of retinopathy and other retinal diseases for early diagnosis and management in patients at risk, to prevent further deterioration and visual loss. A basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. It may also be used in an off-the-shelf desktop, laptop or tablet computer.Class IIaiCare RETCAD is a stand-alone medical device software that analyses colour fundus retinal images to provide results for clinical decision support relating to Age-related Macular Degeneration, Diabetic Retinopathy and Glaucoma. It utilizes artificial intelligence (AI) algorithm to assess and perform interpretation of diagnostic images acquired by retinal imaging devices.
510810Imbio Inc4D Medical LimitedAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIaThe device is an interpretive software program intended to analyse chest x-ray or CT images to identify anatomical structures and provide quantitative measurements, such as the right-to-left ventricular (RV/LV) diameter ratio. It is compatible with standard medical imaging formats (e.g. DICOM) and is intended to suport, not replace, clinical judgement.
511525Overjet IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn interpretive software program intended to be used to analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localization and classification of teeth, detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants); it utilizes artificial intelligence (AI)/deep learning algorithms.Class IIaA radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on permanent teeth captured on periapical radiographs. The device provides additional aid for the dentist to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that considers other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists.
511529Overjet IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn interpretive software program intended to be used to analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localization and classification of teeth, detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants); it utilizes artificial intelligence (AI)/deep learning algorithms.Class IIaA radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment. The intended patient population of the device is patients that have primary and mixed dentition, and are 4-11 years old. The target users are professionally trained and licensed dentists.
511566Carl Zeiss Meditec AGCarl Zeiss Pty LtdAn application software designed to provide algorithms to assist a surgeon in performing calculations to help predict the amount of postoperative corneal astigmatism that needs to be corrected in order to optimize intraocular lens (IOL) model selection and axis placement within the capsular bag and/or to help the surgeon estimate the IOL optical power that will result in optimum correction of myopia. The software is used via an Internet connection utilizing a web browser (e.g., Microsoft Internet Explorer). The applicable IOL labelling provides the URL address for the surgeon.Class IIaAn algorithm intended for the prediction of the post-operative residual refraction for a given eye biometry and intraocular lens power.
511732Medicalgorithmics SAMDG Australia Pty LtdA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] and/or include the ability to record images and movies.Class IIbCloud-based software for the assessment of cardiac arrhythmias using a single- or two-lead ECG data from adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result.
512174Neusoft Medical Systems Co LtdStonestar Wholesale Pty LtdA diagnostic x-ray computed tomography (CT) system with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce 2 and/or 3-dimensional cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.Class IIbThe NeuViz 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Operator & Doctors use the CT scanner to scan the patient and perform post image processing for diagnoses of the patient.
512268Overjet IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn interpretive software program intended to be used to analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localization and classification of teeth, detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants); it utilizes artificial intelligence (AI)/deep learning algorithms.Class 1A Medical Image Management and Processing System (MIMPS) to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image analysis. The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth. The device is not intended as a replacement for a complete clinician’s review or clinical judgment that considers other relevant information from the image or patient history.
512405MyCardium AI LtdMedEnvoy Global Pty LtdAn individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a dedicated computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. A basic set of applications programs and routines are included for such computer-controlled imaging and can be upgraded to correct programming errors or to add new system capabilities. Some must be used with specific configurations to function as intended. An application program package is typically identified by a proprietary name and "version" or "upgrade" number.Class IIbEchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report.
512434ClariPi IncJY Medical Solutions Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIbClariPulmo is a non-invasive image analysis software for use with CT images which is intended to aid the assessment of lung lesions (e.g., emphysema, pneumonia, nodules, etc). The software is designed to support the physician in confirming the presence or absence as well as quantification of physician identified lung lesions. The software will provide automated segmentation of the lungs and quantification of low-attenuation and high-attenuation areas within the segmented lungs by using predefined Hounsfield unit thresholds. The software will also provide automated detection, segmentation, and quantification of lung nodules. The software displays by color the segmented lungs and identified lesions. ClariPulmo provides optional denoising and kernel normalization functions for an improved detection and quantification of lung lesions in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels.
513186Shanghai United Imaging Healthcare Co LtdUnited Imaging Healthcare (Australia & New Zealand) Pty LtdA stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.Class IIbThe system is used to perform image guidance in diagnostic, intervention and surgical procedures. Procedures that can be performed with the system include cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography and whole body radiographic/fluoroscopic procedures.
513187Shanghai United Imaging Healthcare Co LtdUnited Imaging Healthcare (Australia & New Zealand) Pty LtdAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.Class IIbAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.
513346Harrison-AI Medical Pty LtdHarrison-AI Medical Pty LtdAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbThis medical device is intended to assist clinicians with the interpretation of radiological imaging studies and provide notification of suspected findings.
513665Smart Alfa Teknoloji San Ve Tic A SEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaNerveblox software is intended to assist qualified healthcare professionals in the identification and highlighting of anatomical structures in ultrasound images to support ultrasound-guided regional anesthesia procedures.
514066Amalgam RX IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaA software program with a patient user interface intended to calculate therapeutic insulin doses, based on both blood glucose data and patient lifestyle/diet data, for the management of diabetes. The software is designed to be used exclusively by the patient and has no clinician facing application, although outputs can be used within the broader context of clinical guidance. It is not considered an in vitro diagnostic (IVD) software application and is not intended for diabetes screening or diagnosis. It is typically used by the patient in the home or similar environment.Class IIbThe iSage Rx/Dose Check device is intended to help adult patients understand and follow their Healthcare Professional’s (HCP) Titration Plan for the following: 
• Titration of basal insulins 
• Titration of combinations of basal insulin and GLP-1 receptor agonists 
Patients using iSage Rx/Dose Check can record their blood glucose levels, view their Healthcare Professional’s dosing plan for supported medications2, and record the medication dose taken. 
iSage Rx/Dose Check connects with the following devices: 
• Glucose meters to transmit Blood Glucose (BG) data. 
• Smart Insulin pens, caps, and attachments to transmit insulin dosage data to iSage Rx/Dose Check and record the dose taken. 
iSage Rx/Dose Check is not intended to replace the care and management provided by a Healthcare Professional trained in the management of diabetes. iSage Rx/Dose Check should not be used by patients with type 1 diabetes, gestational diabetes, or patients using an insulin pump.
514145Cercle AIVicki Partridge Pty LtdAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks.Class 1The Cercle.AI software is a standalone device intended to assist the relevant medical practitioners, such as an obstetrician or gynaecologist certified in reproductive endocrinology, with personalized care insights and possible treatment outcomes based on similar patient biomedical profiles and similar embryo characteristics.
514167AliveCor IncAlive Technologies Pty LtdAn individual dedicated software program, routines and/or algorithms used as or in an information system to receive, collect, store, assist in data analysis/management, display, output and distribute information within one healthcare facility or among many healthcare facilities to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.Class IIbAliveCor’s Corvair ECG analysis system assists the​ healthcare professional (HCP) in measuring and​ interpreting resting diagnostic ECGs for rhythm and​ morphological information by providing an initial​ automated interpretation. The interpretation by the​ analysis program may then be confirmed, edited, or​ deleted by the HCP. The analysis program is intended for​ use in the general population ranging from healthy​ subjects to patients with cardiac and/or non-cardiac​ abnormalities. Corvair is intended for use by healthcare​ professionals, or trained personnel in healthcare facilities​ (e.g. the doctor’s office or hospital) and in acute settings.​ Corvair analyses should be used only as an adjunct to​ clinical history, symptoms, and the results of other non-invasive and/or invasive tests. Corvair analyses are​ considered unconfirmed and must be reviewed by a​ qualified physician. The provisional automated ECG​ analysis should not be used for clinical action if it has not​ been reviewed by a qualified healthcare professional​ capable of independently interpreting the ECG signal.
515175Zetta 25 AGDentsply Sirona Pty LtdA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.Class IIaDS Core Resto is a front-end software that is intended to be used by dental professionals for the following purposes: 
- design of the crown and inlay/onlay. 
- reviewing and approving the design for a dental restoration and appliance based on the clinical and aesthetic suitability. 
- orienting digital dental models for further usage
- drawing preparation margins on digital dental models for further usage.
515245Qure.ai Technologies Private LimitedAA-Med Pty LtdAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbqSuite is a Computer-aided detection (CAD) and notification software intended to be used in the analysis of radiological scans.
516525Artrya LtdArtrya LtdAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbSalix is a software application that is intended to assist health professionals assess patients at
risk of coronary artery disease. The software post-processes CT images using artificial
intelligence algorithms to detect and localize radiological findings.
Salix is used as an adjunctive tool and is not intended as a replacement to a health
professional’s comprehensive review or their clinical judgment that considers other
information from the CT images and the patient history.
517625EOS ImagingAlphatec Australia Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines packages) must be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaThis cloud-based software is intended for orthopedic applications in both pediatric and adult populations. 
2D X-ray images acquired in EOS imaging’s imaging systems is the foundation and resource to display the interactive landmarks overlayed on the frontal and lateral images. These landmarks are available for users to assess patient-specific global alignment. 
For additional assessment, alignment parameters compared to published normative values may be available. 
This product serves as a tool to aid in the analysis of spinal deformities and degenerative diseases, and lower limb alignment disorders and deformities through precise angle and length measurements. It is suitable for use with adult and pediatric patients aged 7 years and older. 
Clinical judgment and experience are required to properly use the software.
5177653D-SideActis Medical Pty LtdAn individual software application program intended to add specific computer-assisted display, processing, and/or analysis capabilities to a computer and/or a computer workstation (e.g., an off-the-shelf desktop or laptop) to prepare for the implantation of an orthopaedic prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant. It is used for the implantation of total- or partial-joint prostheses typically of the knee, hip, shoulder, or ankle.Class IIaCustomize is a software interface intended to assist in the visualisation and planning of orthopaedic, cranio-maxillofacial, and cranioplasty surgeries, including the communication of treatment options. It enables segmentation of CT and MRI data, supports co-registration of multimodal images, and facilitates preoperative planning of orthopaedic, cranio-maxillofacial, and cranioplasty surgeries.
518026Novarad CorporationEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaA mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.Class IIbThe VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or iliac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
VisAR displays a virtual screen for stereoscopic 3D or 2D images acquired from CT sources. It is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the anatomy of the patient in order to support intraoperative analysis and guidance.
The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in visualization and trajectory planning for both open and percutaneous surgeries.
518428Coreline Soft Co LtdCompliance Management SolutionsAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbThis software is used to store, transfer and display output results by inquiring and analyzing medical images with segmentation and quantification functions. It provides to the physician quantitatively in the diagnostic aid, evaluation, and documentation by providing image segmentation of sub-structures. This software must be used by a medical expert (e.g., physician, radiologist) who is very aware of the anatomic structures of a patient.
518946Artrya LtdArtrya LtdAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbSalix Coronary Plaque is a web-based, non-invasive software application that is intended to be
used for viewing, post-processing, and analyzing cardiac computed tomography (CT) images
acquired from a CT scanner in a Digital Imaging and Communications in Medicine (DICOM)
Standard format.
This software provides cardiologists and radiologists with interactive tools that can be used for
viewing and analyzing cardiac computed tomography (CT) data for quantification and
characterization of coronary plaques (i.e. atherosclerosis), stenosis and to perform calcium
scoring in non-contrast cardiac CT.
Salix Coronary Plaque is intended to complement standard care as an adjunctive tool and is not
intended as a replacement to a medical professional’s comprehensive diagnostic decision-
making process. The software’s semi-automated features are intended for an adult population
and should only be used by qualified medical professionals experienced in examining and
evaluating cardiac CT images.
Users should be aware that certain views make use of interpolated data. These data are created by
the software based on the original data set. Interpolated data may give the appearance of healthy
tissue in situations where pathology that is near or smaller than the scanning resolution may be
present.
519625Alerte Digital Health Pte LtdAlerte Digital Health Pte LtdA data program designed for use in, or together with, an electrocardiogram, Holter analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in ordinary computers e.g. table-top or lap-top, which then perform the product's intended use.Class IIaAtrio Plus is designed to assist healthcare professionals in reviewing and interpreting ambulatory ECG recordings to identify arrhythmic events and support clinical decisions. It is not intended for real-time monitoring, emergency diagnostics, or paediatric applications.
The ECG AI software developed by Alerte Digital Health serves as a medical device intended to assist medical practitioners or trained personnel working under their supervision and direction in the review and analysis of ECG readings. The software also enables reports to be generated. Diagnosis of cardiac conditions and decisions regarding treatment of patients is the responsibility of the medical practitioner. 
The Atrio Plus product is a combination of AI algorithms and diagnostic workbench tools. The ECG AI algorithm is designed to compliment the ECG diagnostic workbench and assist in the evaluation and  management of various cardiac conditions and diseases. 
A summary of indications for using Atrio Plus include: Syncope, pre‑syncopal episodes, palpitations where episodes are occurring more than once a week, another asymptomatic arrhythmia is suspected with an expected frequency of greater than once a week and surveillance following cardiac surgical procedures that have an established risk of causing dysrhythmia.
Atrio Plus has been tested to reliable detect: AF (Atrial Fibrillation), Bradycardia, Tachycardia, Atrial and Ventricular Couplets and Triplets, Atrial and Ventricular Late Beats, Atrial and Ventricular Runs, Atrial and Ventricular Bigeminy and Trigeminy, Premature Atrial and Ventricular Contractions, Pause, Ventricular Ectopic Beats, Interpolated Premature Ventricular Contractions, R on T Beat, Noise, Minimum Heart Rate, Maximum Heart Rate and Average Heart Rate. The automated analysis explicitly does not include ST segment, QT interval, or any other automated morphological analysis.
Exclusions for Morphological Analysis: Does not include automated evaluation of ST segment, QT interval, or other morphological abnormalities; these require manual interpretation by qualified prefessionals. 
Declared Limitations:
To ensure safe and appropriate use of the device:
- Not indicated for use in patients under 18 years of age.
- Not validated for rhythms influenced by pacemakers or defibrillators.
- Not intended for acute care or hospital telemetry settings.
- Not validated for detection of ST-elevation, ischemia, or myocardial infarction.
- Not designed for arrhythmia diagnosis without clinician oversight.
- AI outputs must be reviewed by trained users; override functionality is provided and required.
519647Hermes Medical Solutions ABCyclomedica Australia Pty LtdA free-standing image processing workstation specifically designed to be networked with one or more nuclear medicine imaging systems, e.g. a gamma camera, PET system or SPECT system. It is sometimes considered to be a component to a PACS system. It differs from the operator console in that it does not contain the controls for the direct operation of the diagnostic imaging system. It is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the operator console. It is has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems.Class IIbVoxel Dosimetry is a software application for nuclear medicine. Based on user input of nuclear medicine image data, Voxel Dosimetry calculates a volumetric map of the distribution of absorbed radiation dose (a dose map) on the voxel level and presents the results to the user. The result can be stored for future analysis. Voxel Dosimetry can calculate the predicted dose map of a different radionuclide or different injected activity based on an image of the first measured radionuclide. The dose distribution estimated by Voxel Dosimetry may guide the decision making for future patient radionuclide therapy treatments or inform radiation protection measures for diagnostic radiopharmaceuticals. The software application can be configured based on user needs.
519706Neusoft Medical Systems Co LtdStonestar Wholesale Pty LtdA diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.Class IIaFor use as a diagnostic patient imaging device that produces images that correspond to the distribution of protons exhibiting MRI characteristics; depends upon the MRI parameters of proton density, flow velocity, spin-lattice relaxation time (Tl), and spin-spin relaxation time
(T2); and displays the soft tissue structure. When films are read by a trained radiologist, MRI images obtain useful diagnostic information. The system is suitable for Total-body imaging.
519789Net Health Systems IncVirtual-Care Pty LtdA device used to determine the dimensions of a wound typically to document changes in wound size during the healing process. The device may be a simple ruler or similar measuring device and/or a tracing film to outline a wound that may utilize an electronic digital tablet to calculate wound area or other dimensions (e.g., length, width, depth)Class ImThe Tissue Analytics Application is a software-only medical device used to measure and document chronic wounds.
519885Holberg EEG ASNatus Neuro Australia Pty LtdA software program intended to acquire and process neurological physiological parameter data [primarily electroencephalographic (EEG)] to assist a healthcare professional in the diagnosis of neurological conditions. It has a general-purpose neurological use and is not dedicated to, e.g., sleep monitoring, psychiatric analysis, or seizure-detection.Class IIaautoSCORE is a software-only decision support product intended to be used with compatible EEG software. It is intended to assist the user when reviewing EEG recordings by assessing the probability that the previously acquired sections of EEG recordings contain abnormalities and classifying these into pre-defined types of abnormality. autoSCORE sends this information to the EEG software to indicate where markers indicating abnormality are to be placed in the EEG.
autoSCORE also provides an overview of the probabilities that EEG recordings between 14 minutes and 4 hours include any abnormalities and the probabilities of specific predefined type of abnormalities they include. For EEG recordings of duration more than 4 hours, autoSCORE indicates the number of segments with duration of 2-4 hours that include any abnormalities and the total number of analyzed segments. The overview for EEG recordings of duration more than 4 hours also provides the number of segments that include specific pre-defined types of abnormalities and the total number of analyzed segments.
The user is required to review the EEG and exercise their clinical judgement to independently make a conclusion supporting or not supporting brain disease.
autoSCORE cannot detect or classify seizures. The recorded EEG activity is not altered by the information provided by autoSCORE. autoSCORE is not intended to provide information for diagnosis but to assist clinical workflow when using the EEG software.
520228Shimadzu Corporation Medical Systems DivisionFujifilm Australia Pty LtdA digital general-purpose mobile diagnostic x-ray system is intended for use in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded, by the addition of hardware/software components. This device group does not cover systems with fluoroscopic or tomographic capabilities.Class IIbA digital mobile diagnostic x-ray system for X-Ray radiography.
520366Hermes Medical Solutions ABCyclomedica Australia Pty LtdA free-standing image processing workstation specifically designed to be networked with one or more nuclear medicine imaging systems, e.g. a gamma camera, PET system or SPECT system. It is sometimes considered to be a component to a PACS system. It differs from the operator console in that it does not contain the controls for the direct operation of the diagnostic imaging system. It is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the operator console. It is has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems.Class IIbAffinity displays, processes and analyzes nuclear medicine and radiology imaging data for investigation of physiological or pathological states. The functionality in Affinity is not intended to replace visual assessment by the intended user. Based on user input of injected activity, Affinity can calculate absorbed radiation dose and may guide the decision making for future selective internal radiation therapy (SIRT). The information obtained from the images, including quantitative analysis, may be used, in conjunction with other patient-related data, to inform clinical management.
520565Neusoft Medical Systems Co LtdStonestar Wholesale Pty LtdA diagnostic x-ray computed tomography (CT) system with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce 2 and/or 3-dimensional cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.Class IIbOperator and Doctors use the CT scanner to scan the patient and perform post image processing for diagnoses of the patient. The scanner can provide detailed information to diagnose, plan treatment for, and evaluate many conditions in adults and children. Additionally, the detailed images
provided by CT scan s may eliminate the need for exploratory surgery.
5208563Shape Trios ASEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.Class ImTRIOS Dx is intended as an aid in the diagnosis of oral health conditions and the assessment of changes in teeth and gingiva.
520865Resonance Health Analysis Services Pty LtdResonance Health Analysis Services Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIaFerriSmart is a standalone software as a medical device indicated for the evaluation of liver R2 and liver iron concentration (LIC) from MRI images for the full spectrum of R2 and LIC known clinically.
520896SBO Hearing A/SAudmet Australia Pty LtdA device that is small enough to be worn almost entirely within the ear canal: a small version of an in-the-ear aid.Class IIaA hearing device that is small enough to be worn almost entirely within the ear canal: a small version of an in-the-ear hearing aid.
521244Apple IncApple Pty LtdAn application software program designed as an Internet-based information system to collect and aggregate a patient's self-care data for provision of a communication channel between the patient and a healthcare professional, to facilitate a patient's self-care by using rules defined during the use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional and/or exercising information, which may include medication administration information captured from enabled injection devices, and to provide care plan, journal, medication advice, and/or messaging functionalities.Class IIaThe Hypertension Notification Feature (HTNF) is a software-only mobile medical application that analyzes photoplethysmography (PPG) data opportunistically collected by Apple Watch to identify patterns that are suggestive of hypertension and provides a notification to the user.
The feature is intended for over-the-counter (OTC) use by adults age 22 and over who have not been previously diagnosed with hypertension. It is not intended to replace traditional methods of diagnosis, to monitor hypertension treatment effect, or to be used as a method of blood pressure surveillance. It is not intended for use during pregnancy. The absence of a notification does not indicate the absence of hypertension.
521602Franklin-AI Pty LtdFranklin-AI Pty LtdAn interpretative software algorithm intended to be applied to a clinical result or set of results obtained through testing in order to identify and/or formulate additional clinical information which may then be used to guide patient management.Class 3Franklin AI Digital Prostate (the Device) is an IVD Software as a Medical Device (SaMD) intended to assist pathologists to detect, localise and summarise prostate histopathological findings during the review of digitised Whole Slide Images (WSI) from prostate needle biopsies and transurethral resection of the prostate prepared from Hematoxylin & Eosin (H&E) stained formalin-fixed paraffin-embedded (FFPE) tissue. The Device is intended as a decision-support tool, not a primary diagnostic device. The Device is intended for use by Pathologists for patients over the age of 18 who have undergone prostate tissue sampling for histopathology diagnosis purposes.
521642Planmeca OyHenry Schein HalasA diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms, zonograms.Class IIbPlanmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images of the dentomaxillofacial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
Planmeca Viso 2D is a system intended to produce two-dimensional (2D) digital x-ray images of the 
dentomaxillofacial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
521927OQEA Pty LtdOQEA Pty LtdAn application software program intended to facilitate clinical management decisions by receiving structured patient data from electronic health records (e.g., demographics, diagnostic, laboratory results) and returning clinical care information (e.g., reminders, suggestions and links to guidelines) to a healthcare professional responsible for patient care. Otherwise known as clinical decision support (CDS) software, it is implemented as a web service (a program that runs on a web server communicating with other software, and that has no user-interface of its own).Class 1This software is intended to support qualified clinicians in their clinical reasoning and diagnostic assessment processes by collecting, organising, and structuring clinical assessment data according to established diagnostic criteria and clinical practice guidelines. The software does not replace clinical judgment and requires mandatory clinician review and ratification of all system-generated clinical content before finalisation.
522093MedicalVR BVLexington Medical ANZ Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIaThe device is a medical imaging visualisation software intended to assist trained healthcare professionals with pre-operative and intra-operative visualisations. The device displays 2D and 3D renderings of DICOM compliant patient images and normal anatomy segmentations derived from patient images as well as tools for manipulation of segmentations and 3D models.
522146Omron Healthcare Co LtdJ A Davey Pty LtdAn application software program designed as an Internet-based information system to collect and aggregate a patient's self-care data for provision of a communication channel between the patient and a healthcare professional, to facilitate a patient's self-care by using rules defined during the use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional and/or exercising information, which may include medication administration information captured from enabled injection devices, and to provide care plan, journal, medication advice, and/or messaging functionalities.Class IIaThis medical device software is intended to record and store single-channel electrocardiogram (ECG) rhythms. This medical device software displays ECG rhythms and detects the presence of atrial fibrillation, normal sinus rhythm, bradycardia and tachycardia. This medical device software is intended for use by patients with known or suspected arrhythmia, or health-conscious individuals in a general household situation.
522239Odin Medical LimitedOlympus Australia Pty LtdAn interpretive software program intended to be used to analyse endoscopic video images to detect and localize suspected abnormalities (e.g., polyps) in real-time; it may in addition be intended to differentiate lesions (e.g., neoplastic versus non-neoplastic). It is intended to be installed on an off-the-shelf desktop or laptop computer, interface with an endoscopic video image processing unit, and will typically apply artificial intelligence (AI)/deep learning techniques to identify abnormalities and overlay visual flags on video images displayed by a monitor.Class IIaA software program using artificial intelligence (AI) to analyse endoscopic video images to detect and  suspected abnormalities (e.g., polyps) in real-time. It interfaces with an endoscopic video image processing unit and highlights the suspected abnormalities on the video image shown on a monitor. The program does not replace the judgement of the health professional.
522432Riverain Technologies IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbClearRead CT is comprised of computer-assisted reading tools designed to aid the radiologist in the detection and characterization of pulmonary nodules during the review of screening and surveillance (low-dose) CT examinations of the chest on a non-oncological patient population. ClearRead CT requires both lungs to be in the field of view and is not intended for monitoring patients undergoing therapy for lung cancer or limited field of view CT scans. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.
522526Fairtility LtdVicki Partridge Pty LtdAn application software program intended to be used as part of an embryo-assessment microscope camera system to store, and allow comparison/evaluation of, acquired embryo images, to assist embryo selection during assisted reproduction/in vitro fertilization (IVF). Typically it allows the user to analyse still images and videos of embryonic growth, to annotate or categorize images, and to store patient medical records. It is intended to be used by healthcare professionals in a clinical setting.Class 1CHLOE EQ is an AI decision support tool that examines early embryo development through acquired embryo time-lapse videos. CHLOE EQ provides relevant health professionals such as a registered medical practitioner with automatic data driven insights (e.g. automatic annotations and predictive algorithms) to assist them in making decisions on how an embryo will be used in treatment.
The device is an adjunct to clinical decision-making, and the final assessment and decision must be made by a relevant health professional.
522535GE Medical Systems LTD also doing business as GE Medical Systems Israel Functioning ImagingGE Healthcare Australia Pty LtdA radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The SPECT and CT portions of the system may be used independently or in combination. The SPECT and CT images may be transferred to other systems for radiation therapy planning or additional uses.Class IIbThe system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using tomographic scanning mode supported by various acquisition types, and a Computed Tomography system which is intended for enabling CT-based correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.
522634Alcidion Aus Pty LtdAlcidion Aus Pty LtdAn application software program, routines, and/or algorithms intended for use as or in an information system to receive, collect, store, manage, assist in analysis of, display, output and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the electronic registration of patient diagnoses and procedures. Data uses include demographic and clinical edits, diagnosis related group (DRG) assignment, and patient clinical complexity level (PCCL) assignment. The device is available for installation into existing mainframe or decentralized computers and networks.Class 1The Miya Precision Concept Detection is software classified as Medical Device Software (MDSW) intended for use by healthcare professionals in a clinical environment. Its purpose is to assist in digital record keeping of patient conditions and procedures by analysing free-text clinical notes and then detecting medical conditions and associated SNOMED CT terms mentioned in the text. The software is designed to support clinical decision-making by reducing cognitive load and simplifying documentation workflows by reducing manual effort searching and selecting concepts. All detected concepts suggested require the clinician to validate before inclusion in the patient's record. The device does not replace the judgment of a qualified healthcare professional and is intended for use only by authorized users with appropriate permissions.
523010DigestaidCellmed Pty LtdAn interpretive software program intended to be used to analyse endoscopic video images to detect and localize suspected abnormalities (e.g., polyps) in real-time; it may in addition be intended to differentiate lesions (e.g., neoplastic versus non-neoplastic). It is intended to be installed on an off-the-shelf desktop or laptop computer, interface with an endoscopic video image processing unit, and will typically apply artificial intelligence (AI)/deep learning techniques to identify abnormalities and overlay visual flags on video images displayed by a monitor.Class IIbDeep Capsule® is a non-invasive deep learning software driven by artificial intelligence (AI) intended to identify and differentiate normal mucosa and small bowel lesions in different images from capsule endoscopy videos. 
It is intended to be used as an adjunct to standard diagnostic practice and does not replace clinical judgement.
523011Mvision AI OyRQSolutions Medical Devices Distribution SupportAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.Class IIbWorkspace+ is a software application intended to receive, display, and process medical data and 3D and 4D images of CT, MRI and CBCT modalities. The system is intended for use by trained medical professionals including, but not limited to, radiation oncologists, medical physicists, and dosimetrists. Users can view, create, and modify contours for regions of interest, including organs at risk, lymph nodes and target volumes. The software provides tools for contour propagation between imaging series and predicting dose distributions from individual patient geometry. The software enables the generation of synthetic CT images for external beam radiotherapy treatment planning.
All generated contours, images, and predicted dose distributions must be reviewed, potentially modified, and validated by qualified healthcare professionals before further use in clinical workflows. Workspace+ is not intended for diagnostic purposes.
523289Brainlab SEBrainlab Australia Pty LtdAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.Class IIbThe device is a radiotherapy treatment planning software. The device is indicated for adults only.
523685Optellum LtdMedEnvoy Global Pty LtdAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a x-ray computed tomography (CT) imaging system configuration. A basic set of applications programs and routines are included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines (packages) must be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.Class IIbVirtual Nodule Clinic (VNC) is a software device used in the tracking, assessment and characterization of incidentally detected pulmonary nodules. VNC includes a computer-aided diagnosis (CADx) function, available only to pulmonologists and radiologists. This automatically analyses user-selected regions of interest (ROI) within lung CT data to provide volumetric and computer analysis based on morphological characteristics. Using only imaging features extracted from the CT image data, an artificial intelligence algorithm calculates a single value, the LCP-CNN score, which is displayed to the user. The LCP-CNN score is analysed relative to LCP-CNN scores generated on a database of cases with known ground-truth using a histogram display format. The LCP-CNN score may be useful in the characterization of pulmonary nodules during image interpretation and may be used as one input to clinical decision making when following published clinical guidelines. VNC’s LCP-CNN score is indicated for the evaluation of incidentally detected solid and semi-solid pulmonary nodules of diameter 5-30mm in patients aged 35 years or above. In cases where multiple abnormalities are present, VNC’s LCP-CNN score can be used to assess each abnormality independently. Note that LCP-CNN is not indicated for lung cancer screening or for nodules of pure ground glass opacity. In addition, the validation data also excluded high contrast CT images, CT images with only calcified nodules (since these are typically considered to be benign), with implants, motion artifacts, missing slices, or cases with greater than 5 nodules. Finally, the validation data excluded patients with history of cancer of less than 5 years to avoid the presence of metastatic lesions. Users other than radiologists and pulmonologists, e.g., clinicians, nurses, nurse practitioners and navigators, may use VNC to view CT images and reports, organize patient management workflow, track patients, record management decisions and organize nodule clinics. For these users, the LCP-CNN score is unavailable.
523707Riverain Technologies IncPhilips Electronics Australia LtdAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It may apply artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].Class IIbClearRead CT is comprised of computer assisted reading tools designed to aid the radiologist in the detection and characterization of pulmonary nodules during the review of screening and surveillance (low-dose) CT examinations of the chest on a non-oncological patient population. ClearRead CT requires both lungs be in the field of view and is not intended for monitoring patients undergoing therapy for lung cancer or limited field of view CT scans. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.
523949Esaote SPAInMed Healthcare Pty LtdA diagnostic magnetic resonance imaging (MRI) system employing permanent magnet technology specifically designed to image only the head and neck or limbs. Extremity imaging systems are typically closed bore designs with cylindrical or rectangular bore openings but can be "open" bore designs. They include MRI systems with conventional extremity imaging capabilities, conventional systems capable of performing spectroscopy or other real-time imaging procedures necessary for interventional and therapeutic MRI applications, and dedicated MR spectroscopy systems.Class IIaThe Magnetic Resonance system produces transversal, sagittal and coronal and oblique cross-section images of limbs and joints. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, imaging portions of the lower limb, including the foot, ankle, calf and knee.
523950Esaote SPAInMed Healthcare Pty LtdA general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly and can be fixed-location, mobile, or transportable. In addition to producing conventional MR images, it can be designed or modified through additional software/hardware modules to perform MR spectroscopy and other real-time imaging procedures necessary for physiologically gated imaging procedures, or MRI mammography and other MRI guided interventional, therapeutic, or surgical applications. It is available in a variety of gantry configurations including closed bore, open bore, open-sided or other patient accessible designs.Class IIaThe Magnetic Resonance system produces transversal, sagittal and coronal and oblique cross-section images of the head, limbs, joints and spinal column. It is intended for imaging the head, imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.
524209Ziosoft IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to radiological digital imaging and communications in medicine (DICOM) image data from a human's body for evaluation. When installed in off-the-shelf computers or other digital electronic processing and display devices it provides viewing, quantification, manipulation, communication, printing and management capabilities for image data from standard modalities [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), single photon emission computed tomography (SPECT), digital mammography].Class IIbZiostation2 Plus is image processing application software consisting of the following protocols: 
CT Liver Analysis CT Liver Analysis is a preoperative planning protocol for Hepatectomy. The protocol analyzes liver vascular and anatomical structures of 3D abdominal CT image, compares with supporting tomographic images. estimates the area of the liver containing the tumor as a resection area, calculates remaining liver volume and analyzes the image with basic volume data analysis functions. This, assists users to plan hepatectomy. 
CT Lung Resection Planning CT Lung Resection Planning is a preoperative planning protocol for Lung Resection operation. The protocol analyzes pulmonary and vascular structure of 3D thoracic CT image and analyzes the image with basic volume data analysis functions. This, assists users to plan lung resection.
524351EnsoData IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].Class IIaA Software as a Medical Device (SaMD) that analyzes physiological signals collected during sleep or wake from compatible third-party devices. It displays signals and data for review by healthcare professionals to aid in the diagnosis of sleep, respiratory, and other disorders. It is intended for use by and on order of a healthcare professional.
524352EnsoData IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].Class IIaA Software as a Medical Device (SaMD) that analyzes photoplethysmogram (PPG) data collected during sleep or wake from compatible third-party devices. It displays signals and data for review by healthcare professionals to aid in the diagnosis of sleep, respiratory, and other disorders. It is intended for use by and on order of a healthcare professional.
524394Nox MedicalTemple Healthcare Pty Ltd T/a Temple Medical & ScientificAn interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].Class IIaDeepRESP is intended as an aid in diagnosis of sleep disorders. Its main purpose is to retrieve and automatically analyse/score sleep study data recorded by Nox Medical devices. The results of the analysed data are transferred to another software for display, manual verification and scoring, and reporting.
524415EnsoData IncEmergo Asia Pacific Pty Ltd T/a Emergo AustraliaAn interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].Class IIaA Software as a Medical Device (SaMD) that manages data transfer between third-party devices and clinical systems. It analyzes sound recording data from compatible third-party devices for use by healthcare professionals to aid in the diagnosis of sleep, respiratory, and other disorders. It is intended for use by and on order of a healthcare professional.
524456Blue Belt Technologies IncSmith & Nephew Pty LtdAn individual software application program intended to add specific computer-assisted display, processing, and/or analysis capabilities to a computer and/or a computer workstation (e.g., an off-the-shelf desktop or laptop) to prepare for the implantation of an orthopaedic prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant. It is used for the implantation of total- or partial-joint prostheses typically of the knee, hip, shoulder, or ankle.Class IIaThe Coriograph Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomical landmarks necessary for alignment and position of the implant are identifiable on patient imaging scans. It is indicated for Unicondylar Knee Replacement and Total Knee Arthroplasty.
524682Digital Logic Kardio Software SAStark MedicalA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] and/or include the ability to record images and movies.Class IIbAn Artificial Intelligence software for automated interpretation and diagnosis for ECG and Holter monitoring.  Is intended to be used by qualified medical professionals, experienced in examining and evaluating ECG/Holter data as a support to provide relevant clinical information.
524748Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek)Natus Neuro Australia Pty LtdA device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumors or lesions on or near the surface of the brain.Class IIaIntended Use (NeuroWorks)
•Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information.
•The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. 
•The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. 
•The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. 
•aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Edge and Spectral Entropy trending functionalities included in NeuroWorks are intended to assist the user while monitoring the state of the brain. The automated event marking function of NeuroWorks is not applicable to these analysis features. 
•NeuroWorks also includes the display of a quantitative EEG plot, Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to DSA. 
•This device does not provide any diagnostic conclusion about the patient’s condition to the user.
Intended Use – SleepWorks 
The SleepWorks software is intended for polysomnography studies. The software allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. 
The SleepWorks allows: 
• Automated analysis of physiological signals that is intended for use only in adults. 
• An optional audio / visual alert for user-defined threshold on calibrated DC input. These alerts are not intended for use as life support, such as vital signs monitoring or continuous medical surveillance in intensive care units. 
• Sleep report templates are provided that summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values, as well as data ranges for trended values. 
SleepWorks software does not provide any diagnostic conclusion about the patient’s condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.
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