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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 radiological software device to predict future breast cancer risk
De Novo Number DEN240047
Device Name Allix5
Requester
clairity, inc.
201 w 5th st., suite 1500
austin,  TX  78701
Contact kris zeschin
Regulation Number892.8500
Classification Product Code
SEZ  
Date Received09/06/2024
Decision Date 05/30/2025
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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