Wireless 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 Wireless Digital Flat Panel Detector.

Pre-market Notification Details

Device IDK221345
510k NumberK221345
Device Name:Wireless 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
ContactJunjie Qian
CorrespondentJunjie Qian
iRay Technology Taicang Ltd. No.33 Xinggang Rd., Taicang Port Economic Technological Development Zone Taicang,  CN 215434
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-09
Decision Date2022-06-16

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