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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K203103
Device Name Synapse 3D, Synapse 3D Base Tools v6.1
Fujifilm Corporation
26-30, Nishiazabu 2-Chome Minato-Ku
Tokyo,  JP 106-8620
Applicant Contact Randy Vader
Fujifilm Medical Systems U.S.A., Inc.
81 Hartwell Avenue Suite 300
Lexington,  MA  02421
Correspondent Contact Jeffrey Wan
Regulation Number892.2050
Classification Product Code
Date Received10/14/2020
Decision Date 02/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No