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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 K151579
Device Name MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact CORDELL L. FIELDS
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact CORDELL L. FIELDS
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received06/11/2015
Decision Date 09/29/2015
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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