510(k) K253704 ยท PIB Diabetic Retinopathy Detection Device
iPredict-DR
| Applicant | iHealthscreen, Inc., Richmond Hill NY, US |
| Decision | Substantially Equivalent, Jul 2, 2026 |
| Received | Nov 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253704
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.