Manufacturer registered with FDA
iRay Group
Shanghai, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1020 registrations outside the US
- Establishments
- 1China
Registered in 10 markets
Where regulators' registries name iRay Group as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | iRay Group | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | IRAY GROUP | 6 | 2017–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | iRay Group | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | IRAY GROUP | 3 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | IRAY GROUP | 2 | 2026–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | iRay Group | 1 | 2025–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | IRAY GROUP | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | iRay Group | 1 | 2026–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | iRay Group | 1 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | iRay Group | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What iRay Group currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | CS 6200 Digital Intraoral X-Ray SensorPluto0000X Digital Intraoral X-ray Imaging SystemPluto0001X Digital Intraoral X-ray Imaging SystemPluto0002X Digital Intraoral X-ray Imaging SystemPluto0002XWPluto0015X Digital Intraoral X-ray Imaging System | 2021 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | iScan | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
iRay Group lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: iRay Imaging Technology (Haining) Limited (2), Iray Technology Taicang , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Oct 2023 | K230998 | Digital Wireless Intraoral X-Ray Sensor | iRay Imaging Technology (Haining) Limited | MUH Digital Extraoral Source X-Ray System |
| 21 Apr 2023 | K230811 | Digital Intraoral X-Ray Sensor | iRay Imaging Technology (Haining) Limited | MUH Digital Extraoral Source X-Ray System |
| 23 Apr 2021 | K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang , Ltd. | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| iRay GroupFDA reg. 3013186032 | Shanghai, China | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052663). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.