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 |