FDR GO FLEX

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 Fdr Go Flex.

Pre-market Notification Details

Device IDK120629
510k NumberK120629
Device Name:FDR GO FLEX
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford,  CT  06902 -6300
ContactPeter Altman
CorrespondentPeter Altman
FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford,  CT  06902 -6300
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-01
Decision Date2012-08-28
Summary:summary

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