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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 K220439
Device Name Viz SDH
Applicant
Viz.ai, Inc.
201 Mission St, 12th Floor
San Francisco,  CA  94105
Applicant Contact Vi Ma
Correspondent
Viz.ai, Inc.
201 Mission St, 12th Floor
San Francisco,  CA  94105
Correspondent Contact Vi Ma
Regulation Number892.2080
Classification Product Code
QAS  
Date Received02/16/2022
Decision Date 07/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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