Manufacturer registered with FDA
iRay Korea Limited
Seoul, South Korea. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1South Korea
Registered in 3 markets
Where regulators' registries name iRay Korea 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 Korea Limited | 1 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | IRAY KOREA LIMITED | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | IRAY KOREA LIMITED | 1 | 2022–2022 | 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 Korea 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 | Pluto0001XPluto0002X | 2021 |
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 KOREA LIMITEDFDA reg. 3015464948 | Seoul, South Korea | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060342). 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.