510(k) K213686 ยท QNP Gastrointesinal Lesion Software Detection System
SKOUT Software
| Applicant | Iterative Scopes, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Aug 12, 2022 |
| Received | Nov 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213686
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.