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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
Applicant
SIEMENS MEDICAL SOLUTIONS USA INC.
53 VALLEY STREAM PARKWAY
MALVERN,  PA  19533
Applicant Contact KIM RENDON
Correspondent
SIEMENS MEDICAL SOLUTIONS USA INC.
53 VALLEY STREAM PARKWAY
MALVERN,  PA  19533
Correspondent Contact KIM RENDON
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/13/2010
Decision Date 10/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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