Focus 43C Detector, TRIMAX 43C 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 Focus 43c Detector, Trimax 43c Detector.

Pre-market Notification Details

Device IDK200622
510k NumberK200622
Device Name:Focus 43C Detector, TRIMAX 43C 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
ContactMeng Li
CorrespondentMeng Li
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 Received2020-03-09
Decision Date2020-04-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.