IDx-DR is an AI-enabled medical device from Digital Diagnostics Inc., listed by FDA (510(k), K203629) with a decision date of 2021-06-10. Review panel: Ophthalmic.
| FDA submission number | K203629 |
|---|---|
| Pathway | 510(k) |
| Company | Digital Diagnostics Inc. |
| Review panel (specialty) | Ophthalmic |
| FDA decision date | 2021-06-10 |
| Decision | Substantially Equivalent |
| Product code | PIB |
| Classification | Diabetic Retinopathy Detection Device |
| Device class | 2 |
| Regulation number | 886.1100 |
| Review time (calendar days) | 181 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Ophthalmic AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.