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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 K190138
Device Name MAGNETOM Aera
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, Mailcode 65-1A
Malvern,  PA  19355
Applicant Contact Cordell L. Fields
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, Mailcode 65-1A
Malvern,  PA  19355
Correspondent Contact Cordell L. Fields
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received01/29/2019
Decision Date 02/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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