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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 K083852
Device Name BIOGRAPH 16 TRUE POINT SYSTEMS
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 innovation drive
knoxville,  TN  37932
Original Contact alaine medio
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received12/24/2008
Decision Date 03/23/2009
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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