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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 K190232
Device Name Synapse PACS
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 Ave
Lexington,  MA  02421
Correspondent Contact Senita Sims
Regulation Number892.2050
Classification Product Code
Date Received02/06/2019
Decision Date 03/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls