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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 K260852
Device Name MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure
Applicant
Siemens Healthineers AG
Siemensstr. 3
Forchheim,  DE 91301
Applicant Contact Friederike Hertle
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Milind Dhamankar
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received03/16/2026
Decision Date 07/31/2026
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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