510(k) K261369 · QNP Gastrointesinal Lesion Software Detection System
GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)
| Applicant | Cosmo Artificial Intelligence - Ai, Ltd., Dublin, IE |
| Decision | Substantially Equivalent, May 29, 2026 |
| Received | Apr 27, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261369
No recall in the FDA data names this 510(k).
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