510(k) K230658 · QNP Gastrointesinal Lesion Software Detection System
SKOUT® system
| Applicant | Iterative Scopes, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Apr 7, 2023 |
| Received | Mar 9, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230658
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.