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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 K241429
Device Name ECHELON Synergy MRI System
Applicant
FUJIFILM Healthcare Corporation
2-1, Shintoyofuta
Kashiwa-shi,  JP 277-0804
Applicant Contact Chaitrali Kulkarni
Correspondent
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Suite 300
Lexington,  MA  02421
Correspondent Contact Chaitrali Kulkarni
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/21/2024
Decision Date 08/13/2024
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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