Digital Radiography CXDI-Pro, Digital Radiography D1

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-pro, Digital Radiography D1.

Pre-market Notification Details

Device IDK221876
510k NumberK221876
Device Name:Digital Radiography CXDI-Pro, Digital Radiography D1
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Canon Inc. 9-1 Imaikami-cho, Nakahara-ku, Kawasaki,  JP 211-8501
ContactAkira Hirai
CorrespondentSaori Sawaki
Ken Block Consulting 800 E. Campbell Road, Suite 202 Richardson,  TX  75081
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-28
Decision Date2022-07-15

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