DIGITAL RADIOGRAPHY CXDI-40G COMPACT

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

CANON U.S.A., INC.

The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Digital Radiography Cxdi-40g Compact.

Pre-market Notification Details

Device IDK090623
510k NumberK090623
Device Name:DIGITAL RADIOGRAPHY CXDI-40G COMPACT
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant CANON U.S.A., INC. ONE CANON PLAZA Lake Success,  NY  11042 -1198
ContactSheila Driscoll
CorrespondentJeff D Rongero
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-03-09
Decision Date2009-03-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.