DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA

Solid State X-ray Imager (flat Panel/digital Imager)

RAYENCE CO., LTD

The following data is part of a premarket notification filed by Rayence Co., Ltd with the FDA for Digital Flat Panel X-ray Detector / 1012wca.

Pre-market Notification Details

Device IDK123345
510k NumberK123345
Device Name:DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant RAYENCE CO., LTD 12946 KIMBERLEY LN Houston,  TX  77079
ContactDave Kim
CorrespondentDave Kim
RAYENCE CO., LTD 12946 KIMBERLEY LN Houston,  TX  77079
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-31
Decision Date2013-03-12
Summary:summary

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