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Panels › Gastroenterology, Urology › Product code QNP · Class 2

Gastrointesinal Lesion Software Detection System

Regulation 876.1520

6510(k)s in 12 months (23 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in QNP

Company510(k)sRecalls
Cosmo Artificial Intelligence - Ai, Ltd.60
Iterative Scopes, Inc.40
Magentiq Eye, Ltd.40
Odin Medical Limited30
Fujifilm Corporation20
Iterative Health20
Chengdu Wision Medical Device Co., Ltd.10
Xiamen Inno Medical Technology Co., Ltd.10
Decided510(k)Device and applicantCode
Sep 12, 2026K260133CADDIE
Odin Medical Limited, GB
QNP
Aug 7, 2026K260567EW10-EC02 Endoscopy Support Program
Fujifilm Corporation, JP
QNP
Aug 5, 2026K252853CAD - Lower GI (EC07-01)
Xiamen Inno Medical Technology Co., Ltd., CN
QNP
May 29, 2026K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)
Cosmo Artificial Intelligence - Ai, Ltd., IE
QNP
Apr 3, 2026K260724MAGENTIQ-COLO (ME-APDS)
Magentiq Eye, Ltd., IL
QNP
Dec 22, 2025K253664SKOUT system
Iterative Health
QNP
Oct 3, 2025K252178MAGENTIQ-COLO (ME-APDS)
Magentiq Eye, Ltd., IL
QNP
Sep 12, 2025K252586CADDIE
Odin Medical Limited, GB
QNP
May 9, 2025K251126SKOUT system
Iterative Health
QNP
Jan 24, 2025K244023MAGENTIQ-COLO (ME-APDS)
Magentiq Eye, Ltd., IL
QNP
Jul 25, 2024K241887GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (
Cosmo Artificial Intelligence - Ai, Ltd., IE
QNP
Jul 24, 2024K240044CADDIE
Odin Medical Limited, GB
QNP
Jul 3, 2024K241508SKOUT® system
Iterative Scopes, Inc.
QNP
Apr 19, 2024K240781SKOUT® system
Iterative Scopes, Inc.
QNP
Jan 12, 2024K233964GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)
Cosmo Artificial Intelligence - Ai, Ltd., IE
QNP
Dec 15, 2023K230751EW10-EC02 Endoscopy Support Program
Fujifilm Corporation, JP
QNP
Jul 25, 2023K223473ME-APDS™; MAGENTIQ-COLO™
Magentiq Eye, Ltd., IL
QNP
May 19, 2023K231143GI Genius System 100 and GI Genius System 200
Cosmo Artificial Intelligence - Ai, Ltd., IE
QNP
Apr 7, 2023K230658SKOUT® system
Iterative Scopes, Inc.
QNP
Aug 12, 2022K213686SKOUT Software
Iterative Scopes, Inc.
QNP
Nov 19, 2021K211326EndoScreener
Chengdu Wision Medical Device Co., Ltd., CN
QNP
Jul 23, 2021K211951GI Genius
Cosmo Artificial Intelligence - Ai, Ltd., IE
QNP
Apr 9, 2021DEN200055GI Genius
Cosmo Artificial Intelligence - Ai, Ltd., IE
QNP

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