Flat Panel Detector

Solid State X-ray Imager (flat Panel/digital Imager)

KA Imaging Inc.

The following data is part of a premarket notification filed by Ka Imaging Inc. with the FDA for Flat Panel Detector.

Pre-market Notification Details

Device IDK201591
510k NumberK201591
Device Name:Flat Panel Detector
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant KA Imaging Inc. 560 Parkside Dr #3 Waterloo,  CA N2l 5z4
ContactSamuel To
CorrespondentAmol Karnick
KA Imaging Inc. 560 Parkside Dr #3 Waterloo,  CA N2l 5z4
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-12
Decision Date2020-09-03

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