DIGITAL RADIOGRAPHY MODEL CXDI-40EG

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

CANON, INC.

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

Pre-market Notification Details

Device IDK050987
510k NumberK050987
Device Name:DIGITAL RADIOGRAPHY MODEL CXDI-40EG
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant CANON, INC. ONE CANON PLAZA Lake Success,  NY  11042 -1198
ContactSheila Driscoll
CorrespondentWilliam J Sammons
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 Received2005-04-19
Decision Date2005-04-27
Summary:summary

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