Synapse 3D Base Tools V6.6

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 Base Tools V6.6.

Pre-market Notification Details

Device IDK221677
510k NumberK221677
Device Name:Synapse 3D Base Tools V6.6
ClassificationSystem, Image Processing, Radiological
Applicant FUJIFILM Corporation 26-30 Nishiazabu, 2-Chome Minato-Ku,  JP 106-8620
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-09
Decision Date2022-11-10

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