Gastrointesinal Lesion Software Detection System
Gastroenterology, Urology · 21 CFR 876.1520
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.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
19 firms currently registered for this product code
Mb Elettronica S.r.l.
Cortona Arezzo, IT
Chengdu Wision Medical Device Co., Ltd.
Chengdu Sichuan, CN
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Shirakawa Olympus Co., Ltd.
NISHISHIRAKAWA-GUN Fukushima, JP
Linkverse S.r.l.
Roma, IT
Cosmo Artificial Intelligence, Ltd
Dublin 2, IE
Magentiq Eye Ltd
Haifa, IL
Fujifilm Healthcare Manufacturing Corporation Hanamaki Office
HANAMAKI-SHI Iwate, JP
Odin Medical Limited
London London, City of, GB
Hoya Corporation Pentax Lifecare Division
Akishima-shi Tokyo, JP
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Fujifilm Corporation Medical Systems Research & Development Center Kaisei
Ashigarakami-Gun Kanagawa, JP
510(k) clearances
22 clearances for this product code
- Fujifilm CorporationAug 7, 2026
K260567 · EW10-EC02 Endoscopy Support Program
- Xiamen Inno Medical Technology Co., Ltd.Aug 5, 2026
K252853 · CAD - Lower GI (EC07-01)
- Cosmo Artificial Intelligence - Ai, Ltd.May 29, 2026
K261369 · GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)
- Magentiq Eye, Ltd.Apr 3, 2026
K260724 · MAGENTIQ-COLO (ME-APDS)
- Iterative HealthDec 22, 2025
K253664 · SKOUT system
- Magentiq Eye, Ltd.Oct 3, 2025
K252178 · MAGENTIQ-COLO (ME-APDS)
- Odin Medical LimitedSep 12, 2025
K252586 · CADDIE
- Iterative HealthMay 9, 2025
K251126 · SKOUT system