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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
510(k) Number K103429
Device Name BIOGRAPH MMR
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
OUO  
Date Received11/22/2010
Decision Date 06/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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