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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name gastrointesinal lesion software detection system
De Novo Number DEN200055
Device Name GI Genius
Cosmo Artificial Intelligence - AI, LTD
riverside ii, sir john rogerson’s quay
dublin,  IE d02 kv60
Contact steven a. kradjian
Regulation Number876.1520
Classification Product Code
Date Received09/08/2020
Decision Date 04/09/2021
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct