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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointesinal Lesion Software Detection System
510(k) Number K261369
Device Name GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)
Applicant
Cosmo Artificial Intelligence - Ai, Ltd.
Riverside Ii
Sir John Rogerson'S Quay
Dublin,  IE D02 KV60
Applicant Contact Nhan Ngo Dinh
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number876.1520
Classification Product Code
QNP  
Date Received04/27/2026
Decision Date 05/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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