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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 K121762
Device Name CARDIAC VX
Original Applicant
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha,  WI  53188
Original Contact michelle huettner
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/15/2012
Decision Date 01/18/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Clinical Trials NCT00877903
Reviewed by Third Party No
Expedited Review No
Combination Product No
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