AI Device Tracker / Gastroenterology-Urology
FDA-authorised AI devices in gastroenterology-urology
27 AI-enabled devices with gastroenterology-urology as the lead FDA review panel, newest first. First in this list: 2018; most recent: 2026-06-04.
| Decision date | Device | Company | FDA record |
|---|---|---|---|
| 2026-06-04 | Instrument Exit Point on Touch Surgery Aide | Covidien, LLC | K253984 · 510(k) |
| 2026-05-29 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | K261369 · 510(k) |
| 2026-04-03 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | K260724 · 510(k) |
| 2026-03-12 | Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA | K250655 · 510(k) |
| 2025-12-22 | SKOUT system | Iterative Health | K253664 · 510(k) |
| 2025-12-05 | Gastric Alimetry | Alimetry , Ltd. | K252504 · 510(k) |
| 2025-10-03 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | K252178 · 510(k) |
| 2025-09-12 | CADDIE | Odin Medical Limited | K252586 · 510(k) |
| 2025-06-27 | Maestro System (REF100) | Moon Surgical | K250984 · 510(k) |
| 2025-06-24 | HyperSnap Surgical System (HSS) | Hypervision Surgical | K250268 · 510(k) |
| 2025-05-09 | SKOUT system | Iterative Health | K251126 · 510(k) |
| 2025-01-24 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye LTD | K244023 · 510(k) |
| 2024-07-25 | 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 | K241887 · 510(k) |
| 2024-07-24 | CADDIE | Odin Medical Limited | K240044 · 510(k) |
| 2024-07-03 | SKOUT® system | Iterative Scopes, Inc. | K241508 · 510(k) |
| 2024-04-19 | SKOUT® system | Iterative Scopes, Inc. | K240781 · 510(k) |
| 2024-01-12 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - AI Ltd | K233964 · 510(k) |
| 2023-12-15 | EW10-EC02 Endoscopy Support Program | FUJIFILM Corporation | K230751 · 510(k) |
| 2023-12-12 | NaviCam ProScan | Ankon Technologies co., ltd | DEN230027 · De Novo |
| 2023-07-25 | ME-APDS; MAGENTIQ-COLO | Magentiq Eye LTD | K223473 · 510(k) |
| 2023-05-19 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - AI Ltd | K231143 · 510(k) |
| 2023-04-07 | SKOUT® system | Iterative Scopes Inc. | K230658 · 510(k) |
| 2022-08-12 | SKOUT Software | Iterative Scopes Inc. | K213686 · 510(k) |
| 2021-11-19 | EndoScreener | Chengdu Wision Medical Device Co., LTD. | K211326 · 510(k) |
| 2021-07-23 | GI Genius | Cosmo Artificial Intelligence - AI Ltd | K211951 · 510(k) |
| 2021-04-09 | GI Genius | Cosmo Artificial Intelligence - AI, LTD | DEN200055 · De Novo |
| 2018-05-25 | TransEnterix Senhance Surgical System | TransEnterix, Inc. | K180163 · 510(k) |
How to read this list
- 510(k) clearance means the FDA found the device substantially equivalent to one already on the market. Most AI devices reach the market this way.
- De Novo is used for new, low-to-moderate risk device types with no existing equivalent; it creates a new device category.
- PMA approval is the strictest route, for higher-risk devices.
- Authorisation means the device may be sold in the US for its stated use. It does not prove that the device improves patient outcomes, and it does not mean your hospital uses it.
- This list covers US FDA decisions only. Approval in the EU (CE marking) or the UK (UKCA) is a separate process.
Source: FDA Artificial Intelligence-Enabled Medical Devices list, downloaded 2026-11-05. Information only, not a recommendation of any device.