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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K120910
Device Name CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
Original Applicant
GE MEDICAL SYSTEMS SCS
283, rue de la miniere
buc,  FR 78530
Original Contact stephen slavens
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/26/2012
Decision Date 06/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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