AVIEW by Coreline Soft is a comprehensive medical imaging software that processes CT images of the lungs and heart. It helps physicians analyze lung tissue quantitatively, characterize lung nodules, evaluate coronary artery calcium, and monitor progression of lung disease. The software provides advanced segmentation, registration, quantitative metrics, and reporting tools, integrating AI techniques such as deep learning and CAD to enhance diagnostic support and workflow efficiency.
Intended Use
AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software could be used to support the physician quantitatively in the diagnosis, follow up evaluation and documentation of CT lung tissue images by providing image segmentation of sub-structures in lung, lobe, airways and cardiac, registration of inspiration and expiration which could analyze quantitative information such as air trapping volume, air trapped index, and inspiration/expiration ratio. And also, volumetric and structure analysis, density evaluation and reporting tools. Characterizing nodules in the lung including measurements like size, volume, HU values, and Lung-RADS classification. Provides coronary artery calcium (CAC) analysis and CAC risk based on age and gender.
Technology
The device uses deep learning algorithms for automatic segmentation of lungs, lobes, airways, and coronary arteries. It performs image registration between inspiration and expiration CT scans and includes AI-powered CAD integration for nodule detection and malignancy scoring. The software supports quantitative measures such as volume doubling time, density metrics, and calcium scoring with Agatston scores and generates PDF reports. Product is DICOM 3.0 compliant and supports networked PACS environments and cloud/mobile access.
Performance
Extensive software verification and validation was performed, including unit tests, system tests, and performance tests covering segmentation, registration, nodule measurement, malignancy scoring, Lung-RADS categorization, and coronary artery calcium analysis. No major or moderate software defects remain. Nonclinical testing sufficed; clinical studies were not needed due to equivalent intended use with predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/18/2020
5 months - 2
FDA Approval
8/26/2020
Other devices from Coreline Soft Co., Ltd
- AVIEW CAC2024 • 510K
- AVIEW Lung Nodule CAD2023 • 510K
- AVIEW2022 • 510K
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