Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)

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 (model: Mars1717v-vsi, Mano4343w).

Pre-market Notification Details

Device IDK201043
510k NumberK201043
Device Name:Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
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 Received2020-04-20
Decision Date2020-05-12

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.