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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K121160
Device Name MAGNETOM SPECTRA
Applicant
SIEMENS MEDICAL SOLUTIONS USA INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355
Applicant Contact NADIA SOOKDEO
Correspondent
SIEMENS MEDICAL SOLUTIONS USA INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355
Correspondent Contact NADIA SOOKDEO
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received04/16/2012
Decision Date 07/16/2012
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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