510(k) K211951 ยท QNP Gastrointesinal Lesion Software Detection System
GI Genius
| Applicant | Cosmo Artificial Intelligence - Ai, Ltd., Dublin, IE |
| Decision | Substantially Equivalent, Jul 23, 2021 |
| Received | Jun 23, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211951
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.