510(k) K213037 ยท PIB Diabetic Retinopathy Detection Device
IDx-DR v2.3
| Applicant | Digital Diagnostics, Inc., Coralville IA, US |
| Decision | Substantially Equivalent, Jun 17, 2022 |
| Received | Sep 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213037
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.