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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 K233964
Device Name GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.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 Received12/15/2023
Decision Date 01/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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