Cleared Special

GI Genius? Module 100 (GGM100.US); GI Genius? Module 200 (GGM200.US); ColonPRO? 4.0 (CPRO40.US); GI Genius? Module 300 (GGM300-US); ColonPRO? 4.0 (CPRO40S-US)

K241887 · Cosmo Artificial Intelligence - Ai, Ltd. · Gastroenterology & Urology
Jul 2024
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K241887 is an FDA 510(k) clearance for the GI Genius? Module 100 (GGM100.US); GI Genius? Module 200 (GGM200.US); ColonPRO? 4.0 (CPRO40.US); GI Genius? Module 300 (GGM300-US); ColonPRO? 4.0 (CPRO40S-US), a Gastrointesinal Lesion Software Detection System (Class II — Special Controls, product code QNP), submitted by Cosmo Artificial Intelligence - Ai, Ltd. (Dublin, IE). The FDA issued a Cleared decision on July 25, 2024, 27 days after receiving the submission on June 28, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1520.

Submission Details

510(k) Number K241887 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2024
Decision Date July 25, 2024
Days to Decision 27 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code QNP — Gastrointesinal Lesion Software Detection System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1520
Definition 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.