Ophthalmology
AEYE-DS
AEYE Health, Inc.
FDA-cleared AI medical device
A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.
FDA Submission Metadata
- Submission number
- K221183
- Decision date
- November 2022
- FDA panel
- Ophthalmic
- Product code
- PIB
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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