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..
FDA 510(k) Cleared Gastrointesinal Lesion Software Detection System Devices (Product Code QNP)
About Product Code QNP - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code QNP since 2021, with 18 receiving FDA clearance (average review time: 97 days).
Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 7 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QNP have taken an average of 55 days to reach a decision - down from 135 days historically, suggesting improved FDA processing for this classification.
QNP devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →