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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 K221733
Device Name MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Applicant Contact Alina Goodman
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Correspondent Contact Alina Goodman
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received06/15/2022
Decision Date 09/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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