FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM

System, X-ray, Tomographic

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 Fujifilm Tomosynthesis Option For Fdr Acselerate Stationary X-ray System.

Pre-market Notification Details

Device IDK121499
510k NumberK121499
Device Name:FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
ClassificationSystem, X-ray, Tomographic
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 CodeIZF  
CFR Regulation Number892.1740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-21
Decision Date2012-11-20
Summary:summary

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