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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated radiological image processing software
510(k) Number K221100
Device Name Viz RV/LV
Applicant
Viz.ai, Inc.
201 Mission Street, 12th Floor
San Francisco,  CA  94105
Applicant Contact Vi Ma
Correspondent
Viz.ai, Inc.
201 Mission Street, 12th Floor
San Francisco,  CA  94105
Correspondent Contact Vi Ma
Regulation Number892.2050
Classification Product Code
QIH  
Date Received04/14/2022
Decision Date 08/29/2022
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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