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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 K203443
Device Name MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, Mailcode 65-1A
Malvern,  PA  19355
Applicant Contact Andrew Turner
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, Mailcode 65-1A
Malvern,  PA  19355
Correspondent Contact Andrew Turner
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received11/23/2020
Decision Date 03/31/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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