FDA Registration
Active
🇰🇷 South Korea
DIGIRAY CORP
Reg #: 3009532935
·
FEI: 3009532935
·
Expires 2026
Products
3
Proprietary Names
17
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- DIGIRAY CORP
- Registration Number
- 3009532935
- FEI Number
- 3009532935
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2F, 43, Munpyeongdong-ro, Daedeok-gu
- City
- DAEJEON
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K151687
Owner / Operator
- Firm Name
- DIGIRAY Corp.
- Operator Number
- 10060999
- Address
- 43, Munpyeongdong-ro
- City
- Daedeok-gu
- State
- Daejeon
- Postal Code
- 34302
- Country
- KR
- Correspondent
- Kye choul Ahn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2019-07-26 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2019-07-26 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2019-07-26 |
Proprietary Names
HeraDent
QuantorView
CR500
ExamVue CR Dental
PAPAYA CR
meX+ dentX
EAI DxScan
Dental CR
Planmeca ProScanner
SPISCAN PRO
ClearVision CR
FireCR Dental
I-SCAN
FireCR Spark
FireCR Flash
ExamvueCR PRO
ERAY
Establishment Types
Manufacture Medical Device