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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 K231143
Device Name GI Genius System 100 and GI Genius System 200
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 Consluting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number876.1520
Classification Product Code
QNP  
Date Received04/21/2023
Decision Date 05/19/2023
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
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