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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
Applicant
Fujifilm Corporation
26-30, Nishiazabu 2-Chome
Minato-Ku, Tokyo,  JP 106-8620
Applicant Contact Randy Vader
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
81 Hartwell Ave.
Lexington,  MA  02421
Correspondent Contact Senita Sims
Regulation Number892.2050
Classification Product Code
LLZ  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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