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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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De Novo Number DEN240071
Device Name neuropacs
Requester
automated imaging diagnostics, llc
9706 sw 34th ln.
gainesville,  FL  32608
Contact david vaillancourt
Classification Product Code
SHO
Date Received12/04/2024
Decision Date 04/03/2026
Decision granted (DENG)
Review Advisory Committee Neurology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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