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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 K163312
Device Name MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard Mail Code 65-1A
Malvern,  PA  19355
Applicant Contact Cordell L Fields
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard Mail Code 65-1A
Malvern,  PA  19355
Correspondent Contact Cordell L Fields
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received11/23/2016
Decision Date 01/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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