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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 K101347
Device Name MAGNETOM AERA; MAGNETOM SKYRA
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA INC.
53 valley stream parkway
malvern,  PA  19533
Original Contact kim rendon
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/13/2010
Decision Date 10/01/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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