Iray Korea L T D

FDA Filings

This page includes the latest FDA filings for Iray Korea L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3015464948
FEI Number	3015464948
Name	IRAY KOREA LIMITED
Owner & Operator	iRay Korea Limited
Contact Address	1833, 18F, 5, Gasan digital 1-ro, Geumch Seoul KR-11 Seoul Teugbyeolsi 08594 KR
Official Correspondent	Johnny Jung 82-2-63356333-x
US Agent	Shaw iRay Imaging Limited 178 1363451 124101875@qq.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	1833, 18F, 5, Gasan digital 1-ro, Geumcheon-gu, Seoul, Republic Seoul Seoul Teugbyeolsi, 08594 KR
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K183713 \| MQB IRAY KOREA LIMITED	Mars1717XF-CSI	2020-04-14
PMN K182551 \| MQB IRAY KOREA LIMITED	Mars1417XF-CSI	2020-04-14
PMN K200622 \| MQB IRAY KOREA LIMITED	Focus 43C; TRIMAX 43C	2020-04-02
PMN K123644 \| MQB IRAY KOREA LIMITED	1717 Flat Panel Detector	2019-12-30
PMN K192512 \| MQB IRAY KOREA LIMITED	TRIMAX 35C	2019-12-12
PMN K192512 \| MQB IRAY KOREA LIMITED	Focus 35C	2019-12-12
GUDID 08800061700015 iRay Korea Limited	Wireless Digital Flat Panel Detector	2019-10-09
PMN K160810 \| MQB IRAY KOREA LIMITED	ViZion+wireless CSI	2019-04-28
PMN K152279 \| MQB IRAY KOREA LIMITED	ViZion+wireless GOS	2019-04-28

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020072733283	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	X-RAY FLAT PANEL DETECTOR 9022.90	5 PKG
2020012420041	Pusan,South Korea -> Savannah, Georgia	X RAY FLAT PANEL DETECTOR HS CODE 9022 90	342 CTN