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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 K123737
Model BIOGRAPH MCT FLOW 20, 40, 64 AND FLOW EDGE128
Device Name BIOGRAPH MCT FAMILY
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 innovation dr.
knoxville,  TN  37932
Original Contact alaine meido, rac
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received12/05/2012
Decision Date 01/29/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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