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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 K173592
Device Name MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Mail Code 65-1a
Malvern,  PA  19355
Applicant Contact Cordell L. Fields
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
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 Received11/21/2017
Decision Date 02/13/2018
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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