Digital Intraoral X-ray Imaging System

System, X-ray, Extraoral Source, Digital

IRay Technology Taicang Ltd.

The following data is part of a premarket notification filed by Iray Technology Taicang Ltd. with the FDA for Digital Intraoral X-ray Imaging System.

Pre-market Notification Details

Device IDK212279
510k NumberK212279
Device Name:Digital Intraoral X-ray Imaging System
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant iRay Technology Taicang Ltd. No. 33 Xinggang Rd. Taicang Port Economic & Technological Development Zone Taicang,  CN 215434
ContactGuo Wu
CorrespondentWei Pan
iRay Technology Taicang Ltd. No. 33 Xinggang Rd. Taicang Port Economic & Technological Development Zone Taicang,  CN 215434
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-20
Decision Date2021-10-07

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