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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 K241222
Device Name Ventripoint Medical System Plus (VMS+) 4.0
Applicant
Ventripoint Diagnostics , Ltd.
18 Hook Ave., Unit 101
Toronto,  CA M6P1T4
Applicant Contact Zhang Cheng
Correspondent
Ventripoint Diagnostics , Ltd.
18 Hook Ave., Unit 101
Toronto,  CA M6P1T4
Correspondent Contact Zhang Cheng
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received05/01/2024
Decision Date 02/26/2025
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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