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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 K071068
Device Name BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 INNOVATION DRIVE
KNOXVILLE,  TN  37932
Applicant Contact CRISTIN WETHERBEE
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 INNOVATION DRIVE
KNOXVILLE,  TN  37932
Correspondent Contact CRISTIN WETHERBEE
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received04/16/2007
Decision Date 05/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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