Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat CORELINE SOFT CO., LTD. makes
CoreLine Soft Co., Ltd. develops radiological Picture Archiving and Communication Systems (PACS) software designed for medical imaging workflows. Their products include tools for image analysis, such as coronary artery calcium scoring (CAC), automated lung nodule detection, and radiation therapy planning. The software also supports model-based reconstruction and lung cancer screening applications.
The company’s portfolio is classified under FDA’s Class II regulatory category and is listed in the FDA’s Unique Device Identifier (UDI) database. The products are intended for use in the United States, adhering to applicable medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does CoreLine Soft Co., Ltd. primarily manufacture?
CoreLine Soft Co., Ltd. specializes in developing radiological Picture Archiving and Communication Systems (PACS) software. These systems are designed to manage, store, and analyze medical imaging data, including tools for coronary artery calcium scoring (CAC), automated lung nodule detection, radiation therapy planning, and model-based reconstruction. The focus is on enhancing workflow efficiency and diagnostic capabilities in radiology.
Where is CoreLine Soft Co., Ltd. based, and what does this mean for its regulatory oversight?
CoreLine Soft Co., Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database lists its products, ensuring traceability and compliance with U.S. medical device requirements. This also means the company must adhere to FDA guidelines for software-as-a-medical-device (SaMD) classification and regulatory submission processes.
Which regulatory registries or databases list CoreLine Soft Co., Ltd.’s devices?
CoreLine Soft Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and use, ensuring transparency and traceability. This inclusion confirms the devices are recognized by the FDA but does not imply approval—only that they are tracked under regulatory oversight.
How are CoreLine Soft Co., Ltd.’s devices classified under FDA regulations?
CoreLine Soft Co., Ltd.’s devices fall under the FDA’s Class II regulatory classification. Class II devices generally pose moderate risk and require special controls to ensure their safety and effectiveness. Since these products are software-based radiological tools (e.g., CAC scoring, lung nodule detection), they are subject to performance standards and post-market surveillance requirements to mitigate risks while supporting clinical decision-making.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689517146
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aview | 1.1 | FDA UDI | Class II | Active |
| Aview Cac | 1.1 | FDA UDI | Class II | Active |
| AVIEW Modeler | 1.1 | FDA UDI | Class II | Active |
| Aview | 2.0 | FDA UDI | Class II | Active |
| Aview Cac | 2.0 | FDA UDI | Class II | Active |
| Aview Rt Acs | 1.1 | FDA UDI | Class II | Active |
| AVIEW Lung Nodule CAD | 1.1 | FDA UDI | Class II | Active |
| Aview | 1.0 | FDA UDI | Class II | Active |
| Aview Lcs | 1.0 | FDA UDI | Class II | Active |
| Aview Lcs | 1.1 | FDA UDI | Class II | Active |
| Aview | 1.1 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.