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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 K192496
Device Name Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
Applicant
Siemens Medical Solutions USA Inc.
40 Liberty Boulevard, Mail Code 65-IA
Malvern,  PA  19355
Applicant Contact Cordell L Fields
Correspondent
Siemens Medical Solutions USA Inc.
40 Liberty Boulevard, Mail Code 65-IA
Malvern,  PA  19355
Correspondent Contact Cordell L Fields
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received09/11/2019
Decision Date 02/28/2020
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
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