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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 K111242
Device Name MAGNETOM AERA AND MAGNETOM SKYRA
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Applicant Contact MICHELLE L BYRNE
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Correspondent Contact MICHELLE L BYRNE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/03/2011
Decision Date 11/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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