MDC: Not HPO. Diagnose, specify, provide? (37)

Is the device intended to do any of the following?

1. Diagnose or screen for a disease or condition that may
   1. lead to the death of a person, or
   2. lead to a severe deterioration in the state of a person’s health without urgent treatment, or
   3. pose a high risk to public health
2. Specify or recommend a treatment or intervention, where the treatment or intervention, or its absence, may:
   1. lead to the death of a person, or
   2. lead to a severe deterioration in the state of a person’s health, or
   3. pose a high risk to public health
3. Provide information as therapy to a person that may result in:
   1. the death of the person, or
   2. a severe deterioration in the state of the person’s health.