FDR D-EVO III Flat Panel Detector System

Solid State X-ray Imager (flat Panel/digital Imager)

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fdr D-evo Iii Flat Panel Detector System.

Pre-market Notification Details

Device IDK192932
501k NumberK192932
Device Name:FDR D-EVO III Flat Panel Detector System
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentKamila Sak
FUJIFILM Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-17
Decision Date2019-11-12

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