Manufacturer registered with FDA
iRay Imaging Technology Taicang Limited
Taicang, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name iRay Imaging Technology Taicang 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 Taicang Limited | 2 device types | — | Below |
| South Korea | MFDS | Manufacturer | iRay Imaging Technology Taicang Limited | 1 | 2020–2020 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | iRay Imaging Technology Taicang Limited | 1 | 2021–2021 | 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 Taicang 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 |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | CS 6200 Digital Intraoral X-Ray SensorPluto0002XWPlutoX 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 | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| iRay Imaging Technology Taicang LimitedFDA reg. 3014544225 | Taicang Jiangsu, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058988). 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.