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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 K123510
Device Name MAGNETOM SKYRA
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  
Date Received11/13/2012
Decision Date 05/17/2013
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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