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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 K220589
Device Name MAGNETOM Skyra Fit
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, Mail Code 65-1A
Malvern,  PA  19355
Applicant Contact Karthik Pillai
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, Mail Code 65-1A
Malvern,  PA  19355
Correspondent Contact Martin Rajchel
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received03/01/2022
Decision Date 05/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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