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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K193658
Device Name Viz ICH
Applicant
Viz.ai, Inc.
555 De Haro St Suite 400
San Francisco,  CA  94107
Applicant Contact Gregory Ramina
Correspondent
Viz.ai, Inc.
555 De Haro St Suite 400
San Francisco,  CA  94107
Correspondent Contact Gregory Ramina
Regulation Number892.2080
Classification Product Code
QAS  
Date Received12/30/2019
Decision Date 03/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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