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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 K241887
Device Name 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)
Applicant
Cosmo Artificial Intelligence - AI Ltd
Riverside II
Sir John Rogerson's Quay
Dublin,  IE D02 KV60
Applicant Contact Ngo Dinh Nhan
Correspondent
Donawa Lifescience Consulting Srl
Piaza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number876.1520
Classification Product Code
QNP  
Date Received06/28/2024
Decision Date 07/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
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