iRay Group

FDA Device Registration & Listing · Shanghai, CN · Registration 3013186032

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013186032
FEI Number
3013186032
Entity Name
iRay Group
City/State/Country
Shanghai, CN
Establishment Address
No.999, Huanqiao Road, Pudong New Area, Shanghai 201315, CN
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
iRay Group (Owner Number: 10052663)
Owner / Operator Contact Address
No.999, Huanqiao Road, Pudong New Area, Shanghai, CN-SH 201315, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251038
PMA Number
N/A

All Registered Proprietary Names

Venu1717X Mano4343T Mano4343X Venu1748V Mercu1717V Luna1012X Wireless Digital Flat Panel Detector Mano2530F Wireless Digital Flat Panel Detector Mano2530A Wireless Digital Flat Panel Detector Mars1417V-PSI Mars1717XF-GSI Mars1417X Wireless Digital Flat Panel Detector Mano4336A Wireless Digital Flat Panel Detector Mano4336F Wireless Digital Flat Panel Detector Mars1417V-TSI & Mano4336W Mars1013X CS 6200 Digital Intraoral X-Ray Sensor Mars1717X Wireless Digital Flat Panel Detector Mano4343F Wireless Digital Flat Panel Detector Mano4343A Wireless Digital Flat Panel Detector Pluto0002XW Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-07-06
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-04-29
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-10-23
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 2016-12-29
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-04-06
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 2021-01-06
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2022-04-03
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 2021-03-11
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2023-11-13
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-08-21

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 Group
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
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
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25
K221008 Shanghai Handy Medical Equipment Co., Ltd. HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) 2022-06-22

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.
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2

Similar Registrations

Registration Number Establishment Name Location
3016256852 KA IMAGING INC. Waterloo Ontario, CA
3011825597 FAIR MEDICAL CO.,LTD Kashiwa Chiba, JP
3038614464 Canon.Inc OHTA-KU Tokyo, JP
9614698 CANON INC. OTAWARA-SHI Tochigi, JP
3003775006 FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office HANAMAKI-SHI Iwate, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013186032. Last updated year: 2026. Please use registration number 3013186032 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.