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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 K152822
Device Name VidiStar HeartView
Applicant
Vidistar, LLC
P.O. Box 8539
Greenville,  SC  29604
Applicant Contact CRAIG WALKER
Correspondent
Translational Science Solutions, LLC
92 Hasell St. #401
Charleston,  SC  29401
Correspondent Contact KATHRYN BECKER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/28/2015
Decision Date 11/25/2015
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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