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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 pathology software algorithm device analyzing digital images for cancer prognosis
De Novo Number DEN240068
Device Name ArteraAI Prostate
Requester
artera, inc.
108 1st st.
los altos,  CA  94022
Contact candice bautista-biddle
Regulation Number864.3755
Classification Product Code
SFH  
Date Received11/25/2024
Decision Date 07/31/2025
Decision granted (DENG)
Classification Advisory Committee Pathology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 Yes
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