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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 K153343
Device Name MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
Applicant
Siemens Medi Cal Solutions, Inc.
40 Liberty Blvd.
Mail Code 65-1a
Malvern,  PA  19355
Applicant Contact JOHN URTZ
Correspondent
Siemens Medi Cal Solutions, Inc.
40 Liberty Blvd.
Mail Code 65-1a
Malvern,  PA  19355
Correspondent Contact JOHN URTZ
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/19/2015
Decision Date 04/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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