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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K252217
Device Name CT VScore+
Applicant
Canon Medical Informatics, Inc.
5850 Opus Pkwy., Suite 300
Minnetonka,  MN  55343
Applicant Contact Jay Vaishnav
Correspondent
Canon Medical Informatics, Inc.
5850 Opus Pkwy., Suite 300
Minnetonka,  MN  55343
Correspondent Contact Jay Vaishnav
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/15/2025
Decision Date 11/28/2025
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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