Intelligent NR

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 Intelligent Nr.

Pre-market Notification Details

Device IDK212269
510k NumberK212269
Device Name:Intelligent NR
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Canon Inc. 9-1 Imaikami-cho, Nakahara-ku Kawasaki,  JP 211-8501
ContactAkira Hirai
CorrespondentGregory Woodard
Ken Block Consulting 800 East Campbell Road, Suite 202 Richardson,  TX  75081
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-20
Decision Date2021-09-17

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