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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 K221619
Device Name ECHELON Oval V6.2 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 Received06/03/2022
Decision Date 01/26/2023
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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