Digital Flat Panel Detector

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

IRay Technology Taicang Ltd.

The following data is part of a premarket notification filed by Iray Technology Taicang Ltd. with the FDA for Digital Flat Panel Detector.

Pre-market Notification Details

Device IDK220536
510k NumberK220536
Device Name:Digital Flat Panel Detector
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant iRay Technology Taicang Ltd. No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang,  CN 215434
ContactGuo Wu
CorrespondentJeffrey Wu
iRay Technology Taicang Ltd. No.33 Xinggang Rd., Taicang Port Economic & Technological Development Taicang,  CN 215434
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-24
Decision Date2022-04-28

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