PlutoX 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 Plutox Digital Intraoral X-ray Imaging System.

Pre-market Notification Details

Device IDK210312
510k NumberK210312
Device Name:PlutoX 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 Ticang,  CN 215434
ContactWei Pan
CorrespondentWei Pan
iRay Technology Taicang Ltd. No.33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Ticang,  CN 215434
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-03
Decision Date2021-04-23

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