Viz ICH

Radiological Computer-assisted Triage And Notification Software

Viz.ai, Inc.

The following data is part of a premarket notification filed by Viz.ai, Inc. with the FDA for Viz Ich.

Pre-market Notification Details

Device IDK193658
510k NumberK193658
Device Name:Viz ICH
ClassificationRadiological Computer-assisted Triage And Notification Software
Applicant Viz.ai, Inc. 555 De Haro St Suite 400 San Francisco,  CA  94107
ContactGregory Ramina
CorrespondentGregory Ramina
Viz.ai, Inc. 555 De Haro St Suite 400 San Francisco,  CA  94107
Product CodeQAS  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-30
Decision Date2020-03-18

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