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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(K) Number K113408
Device Name Q. FREEZE (MOTION VUE2)
Applicant
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha,  WI  53188
Contact david duersteler
Regulation Number892.1200
Classification Product Code
KPS  
Date Received11/28/2011
Decision Date 02/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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