Not currently registered with FDA under this name
Iray Technology Taicang , Ltd.
Taicang, China. Named as applicant on 4 dental 510(k) clearances between 2021 and 2023. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42021–2023
- Markets registered in
- 714 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Iray Technology Taicang , Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Iray Technology Taicang , Ltd. | 4 clearances | 2021–2023 | Below |
| Colombia | INVIMA | Manufacturer | IRAY TECHNOLOGY TAICANG LTD. | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | iRay Technology Taicang Ltd. | 3 | 2022–2022 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | iRay Technology Taicang Ltd. | 2 | 2020–2020 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | IRAY TECHNOLOGY TAICANG Ltd. | 2 | 2021–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | iRay Technology Taicang Ltd. | 2 | 2021–2022 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | iRay Technology Taicang Ltd | 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
510(k) clearances
Clearances on which FDA names Iray Technology Taicang , Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Jan 2023 | K223010 | Portable X-ray System | EHD Extraoral with Timer X-Ray Unit |
| 11 Mar 2022 | K220422 | Dental sensors NanoPix1, NanoPix2 | MUH Digital Extraoral Source X-Ray System |
| 7 Oct 2021 | K212279 | Digital Intraoral X-ray Imaging System | MUH Digital Extraoral Source X-Ray System |
| 23 Apr 2021 | K210312 | PlutoX Digital Intraoral X-Ray Imaging System | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: iRay Imaging Technology (Haining) Limited (1), Changzhou Sifary Medical Technology Co., Ltd. (1), Beyes Dental Inc (1), Onvet Medical Canada Inc. (1), Guilin Woodpecker Medical Instrument Co., Ltd. (1), Trident SRL (1).
Sources
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 of the most recent filing, which can be a US agent.