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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 image acquisition and/or optimization guided by artificial intelligence
De Novo Number DEN190040
Device Name Caption Guidance
Requester
bay labs, inc.
290 king street
san francisco,  CA  94107
Contact sam surette
Regulation Number892.2100
Classification Product Code
QJU  
Date Received08/27/2019
Decision Date 02/07/2020
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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