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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
Fujifilm Healthcare Corporation
2-1, Shintoyofuta
Kashiwa-Shi,  JP 277-0804
Applicant Contact Randy Vader
Fujifilm Healthcare Americas Corporation
81 Hartwell Avenue
Suite 300
Lexington,  MA  02421
Correspondent Contact Kotei Aoki
Regulation Number892.1000
Classification Product Code
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