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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 K223042
Device Name Viz LVO ContaCT
Applicant
Viz.ai, Inc.
201 Mission St
12th Floor
San Francisco,  CA  94105
Applicant Contact Gregory Ramina
Correspondent
Viz.ai, Inc.
201 Mission St
12th Floor
San Francisco,  CA  94105
Correspondent Contact Gregory Ramina
Regulation Number892.2080
Classification Product Code
QAS  
Date Received09/29/2022
Decision Date 10/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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