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iRay Group: FDA-registered device maker in Shanghai, China, 19 510(k) clearances

Name: iRay Group FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

iRay Group is registered with the FDA (registration 3013186032) in Shanghai, China. It lists 4 device types. The FDA files 19 510(k) clearances under its listings, the newest dated August 6, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013186032
Address: No.999, Huanqiao Road, Pudong New Area, Shanghai, China, 201315
Owner or operator: iRay Group (10052663)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: December 29, 2016
Registered through: 2026
Brand names listed: CS 6200 Digital Intraoral X-Ray Sensor, Digital Radiographic Imaging Acquisition Software - DR (RiasDR), Luna1012X Wireless Digital Flat Panel Detector, Mano2530A Wireless Digital Flat Panel Detector, Mano2530F Wireless Digital Flat Panel Detector, Mano4336A Wireless Digital Flat Panel Detector, Mano4336F Wireless Digital Flat Panel Detector, Mano4343A Wireless Digital Flat Panel Detector and more

Devices it lists

Device	Product code	Class	Role	Source
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 6, 2025	K251038	Digital Radiographic Imaging Acquisition Software - DR (RiasDR)	LLZ	Substantially Equivalent	Shen Zhen Cambridge-Hit Co., Ltd.	accessdata.fda.gov
October 20, 2023	K230998	Digital Wireless Intraoral X-Ray Sensor	MUH	Substantially Equivalent	Iray Imaging Technology (Haining) Limited	accessdata.fda.gov
April 21, 2023	K230811	Digital Intraoral X-Ray Sensor	MUH	Substantially Equivalent	Iray Imaging Technology (Haining) Limited	accessdata.fda.gov
February 3, 2023	K230059	Digital Flat Panel Detector	MQB	Substantially Equivalent	Ray Imaging Technology (Haining) Limited	accessdata.fda.gov
October 20, 2022	K222886	Mercu 1717V	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
June 29, 2022	K221714	Flat Panel Detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
June 16, 2022	K221345	Wireless Digital Flat Panel Detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
April 28, 2022	K220536	Digital flat panel detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
April 1, 2022	K220668	Wireless Digital Flat Panel Detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
April 23, 2021	K210312	PlutoX Digital Intraoral X-Ray Imaging System	MUH	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
March 3, 2021	K210316	Mars 1417X Wireless Digital Flat Panel Detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
March 2, 2021	K210314	Mars1717X Wireless Digital Flat Panel Detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
May 12, 2020	K201043	Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
May 1, 2020	K201004	Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
January 9, 2019	K183713	Wireless Digital Flat Detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
January 9, 2019	K183422	Wireless Digital Flat Panel Detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
October 17, 2018	K182551	Wireless Digital Flat Panel Detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
October 17, 2018	K182550	Wireless Digital Flat Panel Detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
December 8, 2016	K161730	Wireless Digital Flat Panel Detector	MQB	Substantially Equivalent	Iray Technology (Shanghai) , Ltd.	accessdata.fda.gov

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Updated August 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.