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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 K252838
Device Name MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
Applicant
Siemens Healthcare GmbH
Henkestr. 127
Erlanger,  DE 91052
Applicant Contact Hertle Friederike
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 Received09/05/2025
Decision Date 12/19/2025
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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