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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 K101550
Device Name BIOGRAPH MCT 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 Received06/04/2010
Decision Date 09/03/2010
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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