510(k) K253664 ยท QNP Gastrointesinal Lesion Software Detection System
SKOUT system
| Applicant | Iterative Health, Cambridge MA, US |
| Decision | Substantially Equivalent, Dec 22, 2025 |
| Received | Nov 20, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253664
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.