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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 K223426
Device Name ECHELON Synergy MRI system
Applicant
FUJIFILM Healthcare Corporation
2-1, Shintoyofuta
Kashiwa-Shi,  JP 277-0804
Applicant Contact Randy Vader
Correspondent
FUJIFILM Healthcare Americas Corporation
81 Hartwell Avenue, Suite 300
Lexington,  MA  02421
Correspondent Contact Kotei Aoki
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/14/2022
Decision Date 07/13/2023
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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