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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 digital cervical cytology slide imaging system with artificial intelligence algorithm
De Novo Number DEN210035
Device Name “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
Requester
hologic inc.
250 campus drive
marlborough,  MA  01752
Contact bryce dzialo
Regulation Number864.3900
Classification Product Code
QYV  
Date Received08/27/2021
Decision Date 01/31/2024
Decision granted (DENG)
Classification Advisory Committee Pathology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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