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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 K181773
Device Name Synapse 3D Optional Tools
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
FUJIFILM Medical Systems U.S.A., Inc.
419 West Avenue
Stamford,  CT  06902
Correspondent Contact Jeffrey Wan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/03/2018
Decision Date 09/25/2018
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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