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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 K250436
Device Name MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
Applicant
Siemens Shenzhen Magnetic Resonance , Ltd.
Siemens Mri Center, Gaoxin C. Ave., 2nd,
Hi-Tech Industrial Park
Shenzhen,  CN 518057
Applicant Contact Li Hai Ting
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Goodman Alina
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received02/14/2025
Decision Date 06/16/2025
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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