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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 K183248
Device Name Synapse Enterprise Viewer Version 1.0
FUJIFILM Corporation
26-30 Nishiazabu, 2-Chome
Minato-Ku Tokyo,  JP 106-8620
Applicant Contact Randy Vader
FUJIFILM Medical Systems U.S.A., Inc
3020 Carrington Mill Blvd
Morrisville,  NC  27560
Correspondent Contact Jeffrey Naveda
Regulation Number892.2050
Classification Product Code
Date Received11/21/2018
Decision Date 04/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No