510(k) K233964 · QNP Gastrointesinal Lesion Software Detection System
GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)
| Applicant | Cosmo Artificial Intelligence - Ai, Ltd., Dublin, IE |
| Decision | Substantially Equivalent, Jan 12, 2024 |
| Received | Dec 15, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233964
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.