Synapse 3D Optional Tools

System, Image Processing, Radiological

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Synapse 3d Optional Tools.

Pre-market Notification Details

Device IDK181773
510k NumberK181773
Device Name:Synapse 3D Optional Tools
ClassificationSystem, Image Processing, Radiological
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford,  CT  06902
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-03
Decision Date2018-09-25
Summary:summary

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