510(k) K253930 ยท QIH Automated Radiological Image Processing Software
Overjet Iris Intelligent Imaging System
| Applicant | Overjet, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Apr 10, 2026 |
| Received | Dec 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253930
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.