FDA Registration
Active
🇰🇷 South Korea
VUNO INC.
Reg #: 3029915548
·
FEI: 3029915548
·
Expires 2026
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- VUNO INC.
- Registration Number
- 3029915548
- FEI Number
- 3029915548
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9F, 479, Gangnam-daero, Seocho-gu
- City
- Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K231398
Owner / Operator
- Firm Name
- VUNO Inc.
- Operator Number
- 10089077
- Address
- 9F, 479, Gangnam-daero, Seocho-gu
- City
- Seoul
- State
- KR-NOTA
- Postal Code
- 06541
- Country
- KR
- Correspondent
- Yeha Lee
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-11-03 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2023-11-03 |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | Class 2 | Radiology | No | 2024-11-18 |
Proprietary Names
VUNO Med-DeepBrain
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
Establishment Types
Manufacture Medical Device