Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014544225

FEI Number

3014544225

Entity Name

iRay Imaging Technology Taicang Limited

City/State/Country

Taicang Jiangsu, CN

Establishment Address

No.33 Xinggang Road, Taicang Port Economic and Technological Development Zone, Taicang Jiangsu 215434, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

iRay Imaging Technology Taicang Limited (Owner Number: 10058988)

Owner / Operator Contact Address

No. 33, Xinggang Road, Taicang Port Economic and Technological Development Zone, Taicang, CN-JS 215434, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pluto0002XW Mars1417X Wireless Digital Flat Panel Detector Mano4336F Wireless Digital Flat Panel Detector Mano4336A Wireless Digital Flat Panel Detector Mars1417V-TSI & Mano4336W CS 6200 Digital Intraoral X-Ray Sensor Mars1717XF-CSI Luna1012X Wireless Digital Flat Panel Detector Mano2530A Wireless Digital Flat Panel Detector Mano2530F Wireless Digital Flat Panel Detector Mercu1717V Focus HD 35 Detector TRIMAX 35C Focus 35C Lux HD 35/43 Mars1717V-VSI and Mano4343W Focus HD 43 Detector Mars1013X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2023-11-13
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-03-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-11-19
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-05-07
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2023-04-22
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-03-07
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-06-16
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-10-25
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-03-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-10-25
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2025-03-27
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-05-13
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-03-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-04-03

Official Correspondent

Wei Pan

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

iRay Imaging Technology Taicang Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.

Similar Registrations

Registration Number	Establishment Name	Location
3042046320	QPIX SOLUTIONS, INC.	Morrisville, NC, US
3020117925	ATHLOS OY	Espoo Uusimaa, FI
2032641	CYBER MEDICAL IMAGING, INC.	Los Angeles, CA, US
3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014544225. Last updated year: 2026. Please use registration number 3014544225 when referencing this establishment in official correspondence.