510(k) K241887 · QNP Gastrointesinal Lesion Software Detection System
GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)
| Applicant | Cosmo Artificial Intelligence - Ai, Ltd., Dublin, IE |
| Decision | Substantially Equivalent, Jul 25, 2024 |
| Received | Jun 28, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241887
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.