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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 whole slide imaging system
De Novo Number DEN160056
Device Name Philips IntelliSite Pathology Solution
Requester
philips medical systems nederland b.v.
veenpluis 4-6
best,  NL 5684 pc
Contact esther abels
Regulation Number864.3700
Classification Product Code
PSY  
Date Received12/01/2016
Decision Date 04/12/2017
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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