20 devices · 11 companies · 2021 to 2026
Product code QNP: Gastrointesinal Lesion Software Detection System
20 devices under product code QNP, 2021 to 2026, from 11 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (20 of 20 here), the regulation, and MAUDE report counts by product code.
Gastrointesinal Lesion Software Detection System. 21 CFR 876.1520, Class II. 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. MAUDE held 2 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| GI Genius Module 300K261369 · 510(k) | Cosmo Artificial Intelligence - Ai, Ltd. | Gastroenterology-Urology | database entry | |
| MAGENTIQ-COLOK260724 · 510(k) | Magentiq Eye, Ltd. | Gastroenterology-Urology | database entry | |
| SKOUT systemK253664 · 510(k) | Iterative Health | Gastroenterology-Urology | database entry | |
| MAGENTIQ-COLOK252178 · 510(k) | Magentiq Eye, Ltd. | Gastroenterology-Urology | database entry | |
| CADDIEK252586 · 510(k) | Odin Medical Limited | Gastroenterology-Urology | database entry | |
| SKOUT systemK251126 · 510(k) | Iterative Health | Gastroenterology-Urology | database entry | |
| MAGENTIQ-COLOK244023 · 510(k) | Magentiq Eye LTD | Gastroenterology-Urology | database entry | |
| GI Genius Module 100K241887 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology | database entry | |
| CADDIEK240044 · 510(k) | Odin Medical Limited | Gastroenterology-Urology | database entry | |
| SKOUT systemK241508 · 510(k) | Iterative Scopes, Inc. | Gastroenterology-Urology | database entry | |
| SKOUT systemK240781 · 510(k) | Iterative Scopes, Inc. | Gastroenterology-Urology | database entry | |
| GI Genius Module 100K233964 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology | database entry | |
| EW10-EC02 Endoscopy Support ProgramK230751 · 510(k) | FUJIFILM Corporation | Gastroenterology-Urology | database entry | |
| ME-APDSK223473 · 510(k) | Magentiq Eye LTD | Gastroenterology-Urology | database entry | |
| GI Genius System 100 and GI Genius System 200K231143 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology | database entry | |
| SKOUT systemK230658 · 510(k) | Iterative Scopes Inc. | Gastroenterology-Urology | database entry | |
| SKOUT SoftwareK213686 · 510(k) | Iterative Scopes Inc. | Gastroenterology-Urology | database entry | |
| EndoScreenerK211326 · 510(k) | Chengdu Wision Medical Device Co., LTD. | Gastroenterology-Urology | database entry | |
| GI GeniusK211951 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology | database entry | |
| GI GeniusDEN200055 · De Novo | Cosmo Artificial Intelligence - AI, LTD | Gastroenterology-Urology | database entry |
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