510(k) DEN180001 ยท PIB Diabetic Retinopathy Detection Device
IDx-DR
| Applicant | Idx, LLC, Iowa City IA, US |
| Decision | Unknown, Apr 11, 2018 |
| Received | Jan 12, 2018 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN180001
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.