FDA Product Code QNP: Gastrointesinal Lesion Software Detection System
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.
Leading manufacturers include Cosmo Artificial Intelligence - Ai, Ltd., Iterative Scopes, Inc. and Magentiq Eye, Ltd..
23
Total
22
Cleared
113d
Avg days
2021
Since
Stable submission activity - 10 submissions in the last 2 years
Review times improving: avg
100d
recently vs 124d historically
FDA 510(k) Cleared Gastrointesinal Lesion Software Detection System Devices (Product Code QNP)
23 devices
Cleared
Sep 12, 2026
CADDIE
Odin Medical Limited
Gastroenterology & Urology
239d
Cleared
Aug 07, 2026
EW10-EC02 Endoscopy Support Program
Fujifilm Corporation
Gastroenterology & Urology
169d
Cleared
Aug 05, 2026
CAD - Lower GI (EC07-01)
Xiamen Inno Medical Technology Co., Ltd.
Gastroenterology & Urology
331d
Cleared
May 29, 2026
GI Genius™ Module 300 (GGM300-US)
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology
32d
Cleared
Apr 03, 2026
MAGENTIQ-COLO (ME-APDS)
Magentiq Eye, Ltd.
Gastroenterology & Urology
29d
Cleared
Dec 22, 2025
SKOUT system
Iterative Health
Gastroenterology & Urology
32d
Cleared
Oct 03, 2025
MAGENTIQ-COLO (ME-APDS)
Magentiq Eye, Ltd.
Gastroenterology & Urology
84d
Cleared
Sep 12, 2025
CADDIE
Odin Medical Limited
Gastroenterology & Urology
28d
Cleared
May 09, 2025
SKOUT system
Iterative Health
Gastroenterology & Urology
28d
Cleared
Jan 24, 2025
MAGENTIQ-COLO (ME-APDS)
Magentiq Eye, Ltd.
Gastroenterology & Urology
28d
Cleared
Jul 25, 2024
GI Genius™ Module 100 (GGM100.US)
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology
27d
Cleared
Jul 24, 2024
CADDIE
Odin Medical Limited
Gastroenterology & Urology
201d
Cleared
Jul 03, 2024
SKOUT® system
Iterative Scopes, Inc.
Gastroenterology & Urology
36d
Cleared
Apr 19, 2024
SKOUT® system
Iterative Scopes, Inc.
Gastroenterology & Urology
29d
Cleared
Jan 12, 2024
GI Genius™ Module 100 (GGM100.US)
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology
28d
Cleared
Dec 15, 2023
EW10-EC02 Endoscopy Support Program
Fujifilm Corporation
Gastroenterology & Urology
273d
Cleared
Jul 25, 2023
ME-APDS™
Magentiq Eye, Ltd.
Gastroenterology & Urology
250d
Cleared
May 19, 2023
GI Genius System 100 and GI Genius System 200
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology
28d
Cleared
Apr 07, 2023
SKOUT® system
Iterative Scopes, Inc.
Gastroenterology & Urology
29d
Cleared
Aug 12, 2022
SKOUT Software
Iterative Scopes, Inc.
Gastroenterology & Urology
263d
Cleared
Nov 19, 2021
EndoScreener
Chengdu Wision Medical Device Co., Ltd.
Gastroenterology & Urology
203d
Cleared
Jul 23, 2021
GI Genius
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology
30d
Not Cleared
Apr 09, 2021
GI Genius
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology
213d
About Product Code QNP - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code QNP since 2021, with 22 receiving FDA clearance (average review time: 113 days).
Submission volume has remained relatively stable over the observed period, with 10 submissions in the last 24 months.
FDA 510(k) Review Time - QNP Product Code
Recent submissions under QNP have taken an average of 100 days to reach a decision - down from 124 days historically, suggesting improved FDA processing for this classification.
QNP devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →