Manufacturer registered with FDA
iRay Imaging Technology (Haining) Limited
Haining, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 22023–2023
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name iRay Imaging Technology (Haining) Limited 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 Imaging Technology (Haining) Limited | 2 clearances | 2023–2023 | Below |
| Colombia | INVIMA | Manufacturer | IRAY IMAGING TECHNOLOGY (HAINING) LIMITED | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | iRay Imaging Technology(Haining) Limited | 1 | 2025–2025 | 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 Imaging Technology (Haining) Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | Canis014D07 | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names iRay Imaging Technology (Haining) Limited as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Oct 2023 | K230998 | Digital Wireless Intraoral X-Ray Sensor | MUH Digital Extraoral Source X-Ray System |
| 21 Apr 2023 | K230811 | Digital Intraoral X-Ray Sensor | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: iRay Group (2), Carestream Dental LLC (1).
Also lists devices cleared under other names
iRay Imaging Technology (Haining) Limited 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 Technology Taicang , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Jan 2023 | K223010 | Portable X-ray System | Iray Technology Taicang , Ltd. | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| iRay Imaging Technology (Haining) LimitedFDA reg. 3023546785 | Haining Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10085791). 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.