The following data is part of a De Novo classification by Idx, Llc with the FDA for Idx-dr.
| DeNovo ID | DEN180001 |
| Device Name: | IDx-DR |
| Classification | Diabetic Retinopathy Detection Device |
| Applicant | IDx, LLC 458 Highway 1 West Iowa City, IA 52246 |
| Contact | Michael D. Abramoff |
| Product Code | PIB |
| CFR Regulation Number | 886.1100 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Ophthalmic |
| Classification Advisory | Ophthalmic |
| Type | Direct |
| Date Received | 2018-01-12 |
| Decision Date | 2018-04-11 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |