Company · IE
Cosmo Artificial Intelligence - Ai, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QNP | Gastrointesinal Lesion Software Detection System | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 2026 | K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) Cosmo Artificial Intelligence - Ai, Ltd., IE | QNP |
| Jul 25, 2024 | K241887 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 ( Cosmo Artificial Intelligence - Ai, Ltd., IE | QNP |
| Jan 12, 2024 | K233964 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) Cosmo Artificial Intelligence - Ai, Ltd., IE | QNP |
| May 19, 2023 | K231143 | GI Genius System 100 and GI Genius System 200 Cosmo Artificial Intelligence - Ai, Ltd., IE | QNP |
| Jul 23, 2021 | K211951 | GI Genius Cosmo Artificial Intelligence - Ai, Ltd., IE | QNP |
| Apr 9, 2021 | DEN200055 | GI Genius Cosmo Artificial Intelligence - Ai, Ltd., IE | QNP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||