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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 K151486
Device Name Biograph mCT and mCT Flow PET/CT Scanners
Applicant
Siemens Medical Solutions USA, Inc.
810 INNOVATION DRIVE
KNOXVILLE,  TN  37932
Applicant Contact ALAINE MEDIO
Correspondent
Siemens Medical Solutions USA, Inc.
810 INNOVATION DRIVE
KNOXVILLE,  TN  37932
Correspondent Contact ALAINE MEDIO
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received06/02/2015
Decision Date 07/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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