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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 cardiovascular machine learning-based notification software
De Novo Number DEN230003
Device Name Viz HCM
Requester
viz.ai, inc.
201 mission st., 12th floor
san francisco,  CA  94105
Contact gregory ramina
Regulation Number870.2380
Classification Product Code
QXO  
Date Received01/10/2023
Decision Date 08/03/2023
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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