Enhanced Feature Software Pack CXDI Series

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 Enhanced Feature Software Pack Cxdi Series.

Pre-market Notification Details

Device IDK190368
510k NumberK190368
Device Name:Enhanced Feature Software Pack CXDI Series
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Canon, Inc. 30-2 Shimomaruko, 3-Chrome, Ohta-Ku Tokyo,  JP 146-8501
ContactYamazaki Tatsuya
CorrespondentKatie Reneson
Ken Block Consulting 800 East Campbell Road, Suite 202 Richardson,  TX  75081
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-15
Decision Date2019-03-13
Summary:summary

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