510(k) K231143 ยท QNP Gastrointesinal Lesion Software Detection System
GI Genius System 100 and GI Genius System 200
| Applicant | Cosmo Artificial Intelligence - Ai, Ltd., Dublin, IE |
| Decision | Substantially Equivalent, May 19, 2023 |
| Received | Apr 21, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231143
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.