Ophthalmology
IDx-DR v2.3
Digital Diagnostics 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
- K213037
- Decision date
- June 2022
- FDA panel
- Ophthalmic
- Product code
- PIB
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Images
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.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.