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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K120315
Device Name SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream parkway
malvern,  PA  19355
Original Contact nadia sookdeo
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/01/2012
Decision Date 04/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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