FDA-Cleared AI Directory
Gastroenterology, Urology AI Cleared by the FDA
Colonoscopy software that flags possible lesions live, while the scope is still moving.
This field is almost entirely one job: spotting possible lesions during a colonoscopy, in real time.
That real-time part is what makes it different from the rest of the directory. Most cleared AI looks at a picture after it is taken. These products are drawing on a live video feed while a doctor is working, which changes the design questions and changes what goes wrong when it is wrong.
The list is longer than most people expect, and it has grown quickly.
Device Types in Gastroenterology, Urology
The FDA sorts cleared AI into named device types. Each one has its own bar to clear, so the type tells you what the product is allowed to claim.
| Device type | What it is allowed to do | Cleared | Latest |
|---|---|---|---|
| Gastrointestinal Lesion Detection Software | Highlights possible polyps on the live video feed during a colonoscopy, while the doctor is still working. | 23 | September 12, 2026 |
Newest Gastroenterology, Urology Clearances
| 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 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance is a regulatory decision about a product, not a recommendation, and it does not measure how well the product works in your own setting. Confirm the current status and the exact cleared indication on the FDA record before you buy.