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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 K131634
Model 5.0
Device Name SYMBIA
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 innovation drive
knoxville,  TN  37932 2751
Original Contact elaine chang
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received06/04/2013
Decision Date 08/16/2013
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
Recalls CDRH Recalls
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