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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 Prioritization Software For Lesions
510(k) Number K213319
Device Name Viz ANEURYSM, Viz ANX
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
QFM  
Date Received10/04/2021
Decision Date 02/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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