PIB
8 FDA 510(k) clearances · Product code
199 daysmedian time to decision
269 days90th percentile
8clearances measured
FDA profile
- Official device name
- Diabetic Retinopathy Detection Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1100
- Medical specialty
- Ophthalmic
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| iPredict-DR (K253704) | iHealthscreen, Inc. | 2026-07-02 |
| AEYE-DS (K240058) | Aeye Health, Inc. | 2024-04-23 |
| EyeArt v2.2.0 (K223357) | Eyenuk, Inc. | 2023-06-16 |
| AEYE-DS (K221183) | Aeye Health, Inc. | 2022-11-10 |
| IDx-DR v2.3 (K213037) | Digital Diagnostics, Inc. | 2022-06-17 |
| IDx-DR (K203629) | Digital Diagnostics, Inc. | 2021-06-10 |
| EyeArt (K200667) | Eyenuk, Inc. | 2020-08-03 |
| IDx-DR (DEN180001) | Idx, LLC | 2018-04-11 |
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