WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE

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

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 Wireless/wired Fdr D-evo Flat Pancel Detector System Model Dr-id600 W/dr-id611se.

Pre-market Notification Details

Device IDK111548
510k NumberK111548
Device Name:WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford,  CT  06902 -6300
ContactKatherine Y Choi
CorrespondentKatherine Y Choi
FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford,  CT  06902 -6300
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-03
Decision Date2011-08-30
Summary:summary

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