Software, Optical Coherence Tomography (OCT)

Type of medical device or related product
General vs. specific use (health condition)
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
WHO list of priority medical devices
EMDN related code(s)
Z12120192
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
GMDN related code(s)
65856
Ophthalmic remote-clinician examination software (An application software program intended to be used by a healthcare professional (e.g., optician, optometrist, ophthalmologist) to participate in/coordinate an eye examination from a remote location while the patient is in the clinic with a technician as part of a telemedicine procedure. It is intended to be used: 1) as a stand-alone software, to allow video communication with the patient, access to patient healthcare records, and to view data relating to the examination in real-time; and 2) to control a medical device(s) [e.g., phoropter] during patient examination.)