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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 radiological computer-assisted triage and notification software
De Novo Number DEN170073
Device Name ContaCT
Viz.Al, Inc.
343 texas st.
san francisco,  CA  94301
Contact gregory ramina
Regulation Number892.2080
Classification Product Code
Date Received09/29/2017
Decision Date 02/13/2018
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct