Data / Medical devices / South Korea / Digiray Corp
Digiray Corp: FDA-registered device maker in Daejeon, South Korea, 3 510(k) clearances
Digiray Corp is registered with the FDA (registration 3009532935) in Daejeon, South Korea. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 3, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009532935
- Address
- 2F, 43, Munpyeongdong-ro Daedeok-gu, Daejeon, South Korea, 34302
- Owner or operator
- DIGIRAY Corp. (10060999)
- Roles
- Manufacturer
- First device listed
- July 26, 2019
- Registered through
- 2026
- Brand names listed
- CR500, ClearVision CR, Dental CR, EAI DxScan, ERAY, ExamVue CR Dental, ExamvueCR PRO, FireCR Dental and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 2015 | K151687 | QuantorView | LLZ | Substantially Equivalent | 3Disc Americas | accessdata.fda.gov |
| January 15, 2014 | K133120 | COMPUTED RADIOGRAPHY SCANNER | MQB | Substantially Equivalent | 3Disc Americas | accessdata.fda.gov |
| September 6, 2013 | K131442 | FIRECR DENTALIMAGING SYSTEM | MUH | Substantially Equivalent | 3Disc Americas | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Extraoral Source, Digital
Updated August 3, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.