FDA 510(k) Application Details - K121434

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K121434
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant SIEMENS MEDICAL SOLUTIONS, INC.
51 VALLEY STREAM PARKWAY
MAIL CODE D02
MALVERN, PA 19355 US
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Contact MICHELLE L BYRNE
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 05/14/2012
Decision Date 11/05/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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