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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
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 Avenue Suite 300
Lexington,  MA  02421
Correspondent Contact Jeffrey Wan
Regulation Number892.2050
Classification Product Code
LLZ  
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
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