FDA Registration
Active
🇰🇷 South Korea
OncoStudio
Reg #: 3036758982
·
FEI: 3036758982
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Oncosoft Inc.
- Registration Number
- 3036758982
- FEI Number
- 3036758982
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 37 Myeongmul-gil Seodaemun-gu
- City
- Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K242994
Owner / Operator
- Firm Name
- OncoSoft
- Operator Number
- 10092859
- Address
- 37 Myeongmul-gil Seodaemun-gu
- City
- Seoul
- State
- KR-11
- Postal Code
- 03776
- Country
- KR
- Correspondent
- Boram Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Image Processing Software For Radiation Therapy | QKB | Class 2 | Radiology | No | 2025-02-27 |
Proprietary Names
OncoStudio
Establishment Types
Manufacture Medical Device