Manufacturer registered with FDA
DIGIRAY Corp.
Daedeok-gu, South Korea. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 940 registrations outside the US
- Establishments
- 1South Korea
Registered in 9 markets
Where regulators' registries name DIGIRAY Corp. 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 | DIGIRAY Corp. | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | DIGIRAY Corp. | 33 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Digiray Corp | 1 | 2022–2022 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DIGIRAY CORP. | 1 | 2026–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DIGIRAY CORP | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Digiray Corp | 1 | — | Pure Global AI |
| Japan | PMDA | Registration holder | ＤＩＧＩＲＡＹ Ｃｏｒｐ． | 1 | 2021–2021 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DIGIRAY CORP. | 1 | 2020–2020 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Digiray Corp. | 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 DIGIRAY Corp. 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 | ClearVision CRCR500Dental CREAI DxScanExamVue CR DentalFireCR DentalI-SCANmeX+ dentXPAPAYA CRPlanmeca ProScanner 1 moreSPISCAN PRO | 2019 |
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
DIGIRAY Corp. 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: 3DISC Americas (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 6 Sep 2013 | K131442 | FIRECR DENTALIMAGING SYSTEM | 3DISC Americas | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DIGIRAY CORPFDA reg. 3009532935 | DAEJEON, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060999). 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.