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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 computer-assisted diagnostic software for lesions suspicious for cancer
De Novo Number DEN170022
Device Name QuantX
Requester
quantitative insights, inc
1452 e 53rd st
chicago,  IL  60615
Contact robert tomek
Regulation Number892.2060
Classification Product Code
POK  
Date Received04/07/2017
Decision Date 07/19/2017
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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