Gastrointestinal Lesion Detection Software
Highlights possible polyps on the live video feed during a colonoscopy, while the doctor is still working.
Almost everything else in this directory looks at a picture after it was taken. This looks at video while the procedure is happening, and draws a box on the screen in front of the doctor.
The target is the polyp that scrolls past the edge of the view while the person driving the scope is concentrating on something else. Missed polyps become cancers, and miss rates in real practice are higher than anyone is comfortable with.
Note the FDA calls this detection. The software says look there. It does not say what the thing is, and it does not decide whether to remove it.
There is a live debate about whether the boxes make doctors better or simply busier, and it is a debate worth having with your own endoscopy team before you buy.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- QNP
- FDA name for it
- Gastrointesinal Lesion Software Detection System
- Rule number
- 21 CFR 876.1520
- Risk class
- Class 2
- Medical field
- Gastroenterology, Urology
Before You Sign Anything
- Ask for the change in adenoma detection rate, and ask whether the study was randomized. This is one of the few areas with real trial evidence, so accept nothing less.
- Ask how many boxes appear on a normal procedure. Too many and your team stops looking at them.
- Ask whether procedure time went up, and by how much, because that is throughput and money.
- Ask how it behaves on a poorly prepped colon, which is where a real list differs from a study.
Who Holds the Most Clearances Here
| Company | Cleared products |
|---|---|
| Cosmo Artificial Intelligence - Ai, Ltd. | 6 |
| Magentiq Eye, Ltd. | 4 |
| Iterative Scopes, Inc. | 4 |
| Odin Medical Limited | 3 |
| Fujifilm Corporation | 2 |
| Iterative Health | 2 |
| Xiamen Inno Medical Technology Co., Ltd. | 1 |
| Chengdu Wision Medical Device Co., Ltd. | 1 |
Every Cleared Product, Newest First
Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| CADDIE | Odin Medical Limited | September 12, 2026 | K260133 |
| EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | August 7, 2026 | K260567 |
| CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | August 5, 2026 | K252853 |
| GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | May 29, 2026 | K261369 |
| MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | April 3, 2026 | K260724 |
| SKOUT system | Iterative Health | December 22, 2025 | K253664 |
| MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | October 3, 2025 | K252178 |
| CADDIE | Odin Medical Limited | September 12, 2025 | K252586 |
| SKOUT system | Iterative Health | May 9, 2025 | K251126 |
| MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | January 24, 2025 | K244023 |
| 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) | Cosmo Artificial Intelligence - Ai, Ltd. | July 25, 2024 | K241887 |
| CADDIE | Odin Medical Limited | July 24, 2024 | K240044 |
| SKOUT® system | Iterative Scopes, Inc. | July 3, 2024 | K241508 |
| SKOUT® system | Iterative Scopes, Inc. | April 19, 2024 | K240781 |
| GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - Ai, Ltd. | January 12, 2024 | K233964 |
| EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | December 15, 2023 | K230751 |
| ME-APDS; MAGENTIQ-COLO | Magentiq Eye, Ltd. | July 25, 2023 | K223473 |
| GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | May 19, 2023 | K231143 |
| SKOUT® system | Iterative Scopes, Inc. | April 7, 2023 | K230658 |
| SKOUT Software | Iterative Scopes, Inc. | August 12, 2022 | K213686 |
| EndoScreener | Chengdu Wision Medical Device Co., Ltd. | November 19, 2021 | K211326 |
| GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | July 23, 2021 | K211951 |
| GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | April 9, 2021 | DEN200055 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.