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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 K103480
FOIA Releasable 510(k) K103480
Device Name THORACIC VCAR
Applicant
Ge Medical Systems, LLC
3000 N. Grandview
Waukesha,  WI  53188
Applicant Contact STEPHEN SLAVENS
Correspondent
Ge Medical Systems, LLC
3000 N. Grandview
Waukesha,  WI  53188
Correspondent Contact STEPHEN SLAVENS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/26/2010
Decision Date 03/07/2011
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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