Gastrointesinal Lesion Software Detection System
FDA product code QNP · Class II (moderate risk) · 21 CFR 876.1520 · Gastroenterology, Urology
A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.
22510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260133 | CaddieQNP · Special | Odin Medical Limited | 09/12/2026SE |
| K260567 | EW10-EC02 Endoscopy Support ProgramQNP · Special | Fujifilm Corporation | 08/07/2026SE |
| K252853 | CAD - Lower GI (EC07-01)QNP · Traditional | Xiamen Inno Medical Technology Co., Ltd. | 08/05/2026SE |
| K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)QNP · Special | Cosmo Artificial Intelligence - Ai, Ltd. | 05/29/2026SE |
| K260724 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 04/03/2026SE |
| K253664 | SKOUT systemQNP · Special | Iterative Health | 12/22/2025SE |
| K252178 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 10/03/2025SE |
| K252586 | CaddieQNP · Special | Odin Medical Limited | 09/12/2025SE |
| K251126 | SKOUT systemQNP · Special | Iterative Health | 05/09/2025SE |
| K244023 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 01/24/2025SE |
| K241887 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0…QNP · Special | Cosmo Artificial Intelligence - Ai, Ltd. | 07/25/2024SE |
| K240044 | CaddieQNP · Traditional | Odin Medical Limited | 07/24/2024SE |
| K241508 | SKOUT® systemQNP · Special | Iterative Scopes, Inc. | 07/03/2024SE |
| K240781 | SKOUT® systemQNP · Special | Iterative Scopes, Inc. | 04/19/2024SE |
| K233964 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0…QNP · Special | Cosmo Artificial Intelligence - Ai, Ltd. | 01/12/2024SE |
| K230751 | EW10-EC02 Endoscopy Support ProgramQNP · Traditional | Fujifilm Corporation | 12/15/2023SE |
| K223473 | Me-Apds; Magentiq-ColoQNP · Traditional | Magentiq Eye, Ltd. | 07/25/2023SE |
| K231143 | GI Genius System 100 and GI Genius System 200QNP · Special | Cosmo Artificial Intelligence - Ai, Ltd. | 05/19/2023SE |
| K230658 | SKOUT® systemQNP · Special | Iterative Scopes, Inc. | 04/07/2023SE |
| K213686 | SKOUT SoftwareQNP · Traditional | Iterative Scopes, Inc. | 08/12/2022SE |
| K211326 | EndoScreenerQNP · Traditional | Chengdu Wision Medical Device Co., Ltd. | 11/19/2021SE |
| K211951 | GI GeniusQNP · Special | Cosmo Artificial Intelligence - Ai, Ltd. | 07/23/2021SE |