AI-enabled medical devices in the ARTG

An 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 to function as intended.

301721

A 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.

A 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.

312072

An 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 application software programs or program packages must be combined specific hardware or firmware accessories or configurations to function as intended. 

Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Medis QFR XA is indicated for use in clinical settings where validated and reproducible quantified results are needed 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 because 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.

316044

BriefCase 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/prioritisation of medical images. 

Notified clinicians are responsible for viewing full images per the standard of care.

329820

A 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).

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.

The 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.

335634

Smilo is a smart device application to provide oral health awareness.

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;
• “Discussion Forum” where registered users may ask questions relating to oral health and the health professional administrators provide responses;
• “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. 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. 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. See your dentist urgently

An interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localise 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].

The Chest X-ray product, qXR analyses all chest radiographs that meets the inclusion criteria. 

qXR detects suspected abnormalities in the Chest X-ray and localises them and primarily provides clinically relevant tags.

Additionally, the software has the capability to provide position of the suspected abnormalities, if relevant. 

The results produced by qXR is intended to be used to support certified Radiologists or other licensed medical practitioner for clinical decision making. 

It is a support tool to assist the clinician (radiologist) used with original radiographs to improve efficiency, accuracy and turnaround time and is not to be used as a source of medical advice or determine treatment plan or recommend a course of action for the patient.

An 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 decentralised computers.

The 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 include the automatic routing/archiving of newly acquired medical scans or the submission of medical scans for AI analysis to a remote cloud server.

An 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].

Us2.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).

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.

The 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.

An 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).

CoTreat 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

An 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].

CINA 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.

The 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.

CINA 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 analyse 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/prioritisation of medical images.

Notified clinicians are ultimately responsible for reviewing full images per the standard of care.

An 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 decentralised computers/network.

An 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].

Medical 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.

The 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 organisations 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.

An 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.

Contour+ (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 visualisation systems as an initial template for a medical professional to visualise, 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.

A 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).

The 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 analyse 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.

The 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.

A 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.

An 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.

The 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.

A 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.

The 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

The 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 organisations 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.

Formus 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.

An 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.

Contour 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.

An 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 to function as intended. 

Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

An 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.

Embryoaid 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.

A 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.

The 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.

The 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.

The 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 analysing 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.

The 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.

An 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 to function as intended.

Limbus 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.
• Localisation and definition of healthy anatomical structures.

Limbus Contour is not intended for use with digital mammography.

An 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.

The 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.

An interpretive software program intended to be used to:

• analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localisation and classification of teeth,
• detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants),
• utilises artificial intelligence (AI)/deep learning algorithms.

An 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 computerised functions to store diagnostic images used for image-guided surgery.

For 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.

An 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.

Intended 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.

CARPL 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 visualising 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 anonymised image remains consistently available. 

This system is designed exclusively for use by proficient and certified medical experts, including physicians, radiologists, and medical technicians.

An 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.

A 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.

The 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.

An 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 categorise images, and to store patient medical records. 

It is intended to be used by healthcare professionals in a clinical setting.

An 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.

A Rehabilitation Gaming System designed for rehabilitation of functional deficits due to brain damage. 

It provides individualised training based on virtual reality for the rehabilitation of the patients helping them to optimally regain function and well-being.

A 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].

A 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].

An 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.

iCare 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 utilises artificial intelligence (AI) algorithm to assess and perform interpretation of diagnostic images acquired by retinal imaging devices.

The 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.

A 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.

A 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.

An 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 to optimise 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 utilising a web browser (e.g., Microsoft Internet Explorer). 

The applicable IOL labelling provides the URL address for the surgeon.

A 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.

Cloud-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.

The 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 and Doctors use the CT scanner to scan the patient and perform post image processing for diagnoses of the patient.

An 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 to function as intended. 

Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

A 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.

The 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.

An 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 utilisation of cardiology services and facilities. 

It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralised computers/networks.

A 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.

DS 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.

A 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 can collect patient demographics, which may be anonymised.

A 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.

Atrio 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 complement 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 professionals. 

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.

A 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 has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine-based imaging systems.

Voxel 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.

A 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.

A 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)

A 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.

A 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 has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine-based imaging systems.

Affinity displays, processes and analyses 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.

An 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.