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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 software algorithm device to assist users in digital pathology
De Novo Number DEN200080
Device Name Paige Prostate
Requester
paige.ai
11 times square 37th floor
new york,  NY  10036
Contact emre gulturk
Regulation Number864.3750
Classification Product Code
QPN  
Date Received12/31/2020
Decision Date 09/21/2021
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		 No
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