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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 K232363
Device Name Viz HDS, Viz Volume Plus, Viz ICH+
Applicant
Viz.ai, Inc.
201 Mission St
12th Floor
San Francisco,  CA  94105
Applicant Contact Pooja Shah
Correspondent
Viz.ai, Inc.
5000 Center Green Way
Cary,  NC  27513
Correspondent Contact Pooja Shah
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/07/2023
Decision Date 02/05/2024
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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