DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless

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 Cxdi-702c Wireless, Digital Radiography Cxdi-402c Wireless.

Pre-market Notification Details

Device IDK192632
501k NumberK192632
Device Name:DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
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
CorrespondentGregory Woodard
Ken Block Consulting 800 East Campbell Road, Suite 202 Richardson,  TX  75081
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-23
Decision Date2019-11-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04549292168679 K192632 000
04549292167436 K192632 000

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