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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 K233687
Device Name ECHELON Synergy V10.0
Applicant
Fujifilm Healthcare Americas Corporation
81 Hartwell Ave Suite 300
Lexington,  MA  02421
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 Received11/17/2023
Decision Date 05/03/2024
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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