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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 K220939
Device Name MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
Applicant
Siemens Medical Solutions USA Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Applicant Contact Alina Goodman
Correspondent
Siemens Medical Solutions USA Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Alina Goodman
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received03/31/2022
Decision Date 04/29/2022
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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