Cosmo Artificial Intelligence - Ai, Ltd.
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories1
Latest FDA decision2026-05-29
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261369 | GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) | QNP | 2026-05-29 | View |
| 510(k) | K241887 | 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) | QNP | 2024-07-25 | View |
| 510(k) | K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) | QNP | 2024-01-12 | View |
| 510(k) | K231143 | GI Genius System 100 and GI Genius System 200 | QNP | 2023-05-19 | View |
| 510(k) | K211951 | GI Genius | QNP | 2021-07-23 | View |
No matching devices.