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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 K183210
Device Name Thoracic VCAR with GSI Pulmonary Perfusion
GE Medical Systems SCS
283 rue de la Miniere
Buc,  FR 78530
Applicant Contact Peter Uhlir
GE Medical Systems, LLC.
3000 North Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Helen Peng
Regulation Number892.2050
Classification Product Code
Subsequent Product Code
Date Received11/19/2018
Decision Date 03/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No