QNP · Class II · 21 CFR 876.1520

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..

20
Total
19
Cleared
94d
Avg days
2021
Since
Declining activity - 7 submissions in the last 2 years vs 9 in the prior period
Review times improving: avg 37d recently vs 124d historically

FDA 510(k) Cleared Gastrointesinal Lesion Software Detection System Devices (Product Code QNP)

20 devices
1–20 of 20
Cleared May 29, 2026
GI Genius™ Module 300 (GGM300-US)
K261369
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 32d
Cleared Apr 03, 2026
MAGENTIQ-COLO (ME-APDS)
K260724
Magentiq Eye, Ltd.
Gastroenterology & Urology · 29d
Cleared Dec 22, 2025
SKOUT system
K253664
Iterative Health
Gastroenterology & Urology · 32d
Cleared Oct 03, 2025
MAGENTIQ-COLO (ME-APDS)
K252178
Magentiq Eye, Ltd.
Gastroenterology & Urology · 84d
Cleared Sep 12, 2025
CADDIE
K252586
Odin Medical Limited
Gastroenterology & Urology · 28d
Cleared May 09, 2025
SKOUT system
K251126
Iterative Health
Gastroenterology & Urology · 28d
Cleared Jan 24, 2025
MAGENTIQ-COLO (ME-APDS)
K244023
Magentiq Eye, Ltd.
Gastroenterology & Urology · 28d
Cleared Jul 25, 2024
GI Genius™ Module 100 (GGM100.US)
K241887
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 27d
Cleared Jul 24, 2024
CADDIE
K240044
Odin Medical Limited
Gastroenterology & Urology · 201d
Cleared Jul 03, 2024
SKOUT® system
K241508
Iterative Scopes, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 19, 2024
SKOUT® system
K240781
Iterative Scopes, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 12, 2024
GI Genius™ Module 100 (GGM100.US)
K233964
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 28d
Cleared Dec 15, 2023
EW10-EC02 Endoscopy Support Program
K230751
Fujifilm Corporation
Gastroenterology & Urology · 273d
Cleared Jul 25, 2023
ME-APDS™
K223473
Magentiq Eye, Ltd.
Gastroenterology & Urology · 250d
Cleared May 19, 2023
GI Genius System 100 and GI Genius System 200
K231143
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 28d
Cleared Apr 07, 2023
SKOUT® system
K230658
Iterative Scopes, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 12, 2022
SKOUT Software
K213686
Iterative Scopes, Inc.
Gastroenterology & Urology · 263d
Cleared Nov 19, 2021
EndoScreener
K211326
Chengdu Wision Medical Device Co., Ltd.
Gastroenterology & Urology · 203d
Cleared Jul 23, 2021
GI Genius
K211951
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 30d
Not Cleared Apr 09, 2021
GI Genius
DEN200055
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 213d

About Product Code QNP - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code QNP since 2021, with 19 receiving FDA clearance (average review time: 94 days).

Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 9 in the prior period.

FDA 510(k) Review Time - QNP Product Code

Recent submissions under QNP have taken an average of 37 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 →