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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 K250354
Device Name Viz Subdural+, Viz SUBDURAL PLUS
Applicant
Viz. Ai, Inc.
5000 Center Green Way
Cary,  NC  27513
Applicant Contact Gregory Ramina
Correspondent
Viz. Ai, Inc.
5000 Center Green Way
Cary,  NC  27513
Correspondent Contact Gregory Ramina
Regulation Number892.2050
Classification Product Code
QIH  
Date Received02/07/2025
Decision Date 06/10/2025
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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