Software, fundus photography

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)
65168
Ophthalmic image analysis software (An application software program intended to be used by: 1) a healthcare professional (e.g., optician, optometrist, ophthalmologist) to analyse, manage, and create reports relating to images of the eye, captured by either a professional ophthalmic device (e.g., slit lamp) or off-the-shelf camera (e.g., smartphone camera); and 2) a patient to upload self-taken images of the eye into their patient record and to receive professional reports. The software is intended to assist professional diagnosis and is not intended for patient self-assessment.)