DIGITAL FLAT PANEL X-RAY DETECTOR

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.

Pre-market Notification Details

Device IDK131114
510k NumberK131114
Device Name:DIGITAL FLAT PANEL X-RAY DETECTOR
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant RAYENCE CO., LTD 8310 BUFFALO SPEEDWAY Houston,  TX  77025
ContactDave Kim
CorrespondentDave Kim
RAYENCE CO., LTD 8310 BUFFALO SPEEDWAY Houston,  TX  77025
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-22
Decision Date2013-09-17
Summary:summary

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