AVIEW is a software product that assists physicians by providing quantitative analysis of CT images for lung and cardiac evaluation. It offers segmentation of lung structures, characterization and measurement of lung nodules, calcium scoring of coronary arteries, and integrates computer-aided detection tools. It can be used both on-premises and in cloud environments, supporting remote access via mobile devices or browsers. This software enhances diagnostic accuracy and aids in patient management by automating complex image analysis tasks.
Intended Use
AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets to support quantitative analysis by image segmentation of lung sub-structures, nodules, fissures, airways, cardiac density, and reporting tools. It also supports storage, transfer, inquiry, and display of CT datasets on-premises and in cloud environments.
Technology
AVIEW is PC-installable software supporting DICOM 3.0 standard for image loading and manipulation, providing functions such as image reading, post-processing, segmentation of lung and cardiac structures, nodule measurement, automatic nodule detection via integration with FDA-cleared CAD software, and calcium scoring of coronary arteries including Agatston scoring and risk assessment.
Performance
The device does not require new clinical studies as it is substantially equivalent to the predicate device. Nonclinical testing verified that the device is safe and effective, and the performance was validated through software verification and validation testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/29/2024
3 months - 2
FDA Approval
3/19/2025
Other devices from Coreline Soft Co., Ltd.
- AVIEW CAC2025 • 510K
- AVIEW CAC2024 • 510K
- AVIEW Lung Nodule CAD2023 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.