510(k) K241887
- Device
- 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.
- 510(k) number
- K241887
- Product code
- QNP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-25
- Date received
- 2024-06-28
- Regulation
- 876.1520
- Classification name
- Gastrointesinal Lesion Software Detection System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ngo Dinh Nhan
- Address
- Riverside Ii Sir John Rogerson'S Quay Dublin IE D02 KV60 D02 KV60
FDA Registration Numbers#
- 3002808148
- 3018899987
- 3016591389
- 3031983124
- 8010047
- 3011050570
- 3030626336
- 3018901422
- 3016432796
- 3003775006
- 9610877
- 3042225166
Source Documents#
Other 510(k) Records For Product Code QNP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260724 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2026-04-03 |
| K253664 | SKOUT system | Iterative Health | 2025-12-22 |
| K252178 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2025-10-03 |
| K252586 | CADDIE | Odin Medical Limited | 2025-09-12 |
| K251126 | SKOUT system | Iterative Health | 2025-05-09 |
| K244023 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2025-01-24 |
| K240044 | CADDIE | Odin Medical Limited | 2024-07-24 |
| K241508 | SKOUT® system | Iterative Scopes, Inc. | 2024-07-03 |
| K240781 | SKOUT® system | Iterative Scopes, Inc. | 2024-04-19 |
| K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-01-12 |
| K230751 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2023-12-15 |
| K223473 | ME-APDS™; MAGENTIQ-COLO™ | Magentiq Eye, Ltd. | 2023-07-25 |
| K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | 2023-05-19 |
| K230658 | SKOUT® system | Iterative Scopes, Inc. | 2023-04-07 |
| K213686 | SKOUT Software | Iterative Scopes, Inc. | 2022-08-12 |