SYNAPSE 3D CARDIAC TOOLS

System, Image Processing, Radiological

FUJIFILM MEDICAL SYSTEM U.S.A., INC.

The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Synapse 3d Cardiac Tools.

Pre-market Notification Details

Device IDK130383
510k NumberK130383
Device Name:SYNAPSE 3D CARDIAC TOOLS
ClassificationSystem, Image Processing, Radiological
Applicant FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford,  CT  06902 -6300
ContactJyh-shyan Lin
CorrespondentJyh-shyan Lin
FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford,  CT  06902 -6300
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-14
Decision Date2013-04-09
Summary:summary

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