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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
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