FDA Registration
Active
🇰🇷 South Korea
CORELINE SOFT CO., LTD.
Reg #: 3015169361
·
FEI: 3015169361
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- CORELINE SOFT CO., LTD.
- Registration Number
- 3015169361
- FEI Number
- 3015169361
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12, Donggyo-ro 19-gil, Mapo-gu
- City
- Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K171199
Owner / Operator
- Firm Name
- Coreline Soft Co., Ltd.
- Operator Number
- 10059497
- Address
- 12, Donggyo-ro 19-gil,, Mapo-gu
- City
- Seoul
- State
- KR-NOTA
- Postal Code
- 04001
- Country
- KR
- Correspondent
- Hye Yi Park
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2019-01-29 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2020-05-05 |
| Lung Computed Tomography System, Computer-Aided Detection | OEB | Class 2 | Radiology | No | 2023-02-27 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-04-21 |
| Radiological Image Processing Software For Radiation Therapy | QKB | Class 2 | Radiology | No | 2022-11-28 |
Proprietary Names
AVIEW
AVIEW LCS
AVIEW Modeler
AVIEW Lung Nodule CAD
AVIEW CAC
AView LCS
AVIEW 2
AVIEW RT ACS
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198