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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 K081453
Device Name BIOGRAPH HD FAMILY
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 innovation dr.
knoxville,  TN  37932
Original Contact alaine medio
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received05/23/2008
Decision Date 06/23/2008
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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