Synapse 3D Cardiac Tools

System, Image Processing, Radiological

FUJIFILM Corporaton

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

Pre-market Notification Details

Device IDK200973
510k NumberK200973
Device Name:Synapse 3D Cardiac Tools
ClassificationSystem, Image Processing, Radiological
Applicant FUJIFILM Corporaton 26-30,Nishiazabu 2-Chome Minato-Ku Tokyo,  JP 106-8620
ContactRandy Vader
CorrespondentTommy San
FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-13
Decision Date2020-08-27

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