DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C 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-710c Wireless, Digital Radiography Cxdi-810c Wireless.

Pre-market Notification Details

Device IDK170332
510k NumberK170332
Device Name:DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Canon, Inc. 9-1, Imaikami-Cho Nakahara-ku, Kawasaki,  JP 211-8501
ContactShinji Mori
CorrespondentDiane Rutherford
Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson,  TX  75080
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-02
Decision Date2017-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04549292099454 K170332 000
04549292099447 K170332 000

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