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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 K133226
Device Name BIOGRAPH MMR
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Applicant Contact NADIA SOOKDEO
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Correspondent Contact NADIA SOOKDEO
Regulation Number892.1200
Classification Product Code
OUO  
Date Received10/21/2013
Decision Date 11/12/2013
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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