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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K191493
Device Name Ventripoint Medical System Plus (VMS+) 3.0
Applicant
Ventripoint Diagnostics, Ltd.
2 Sheppard Avenue East, Suite 605
Toronto,  CA M2N 5Y7
Applicant Contact Desmond Hirson
Correspondent
Ventripoint Diagnostics, Ltd.
2 Sheppard Avenue East, Suite 605
Toronto,  CA M2N 5Y7
Correspondent Contact Desmond Hirson
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
ITX   IYN   IYO  
Date Received06/05/2019
Decision Date 10/16/2019
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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