IDx-DR is an AI-enabled medical device from IDx, LLC, listed by FDA (De Novo, DEN180001) with a decision date of 2018-04-11. Review panel: Ophthalmic.
| FDA submission number | DEN180001 |
|---|---|
| Pathway | De Novo |
| Company | IDx, LLC |
| Review panel (specialty) | Ophthalmic |
| FDA decision date | 2018-04-11 |
| Decision | Unknown |
| Product code | PIB |
| Classification | Diabetic Retinopathy Detection Device |
| Device class | 2 |
| Regulation number | 886.1100 |
| Review time (calendar days) | 89 |
| 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.