AVIEW CAC
Coreline Soft Co., Ltd.AVIEW CAC is a software that analyzes non-contrast chest CT scans to quantify calcified plaques in coronary arteries, calculate the Agatston score, and provide risk stratification based on calcium scoring, age, and gender. It helps radiologists and cardiologists by supporting image storage, transfer, and display, facilitating clinical decision-making for coronary artery disease risk assessment.
Intended Use
AVIEW CAC provides quantitative analysis of calcified plaques in the coronary arteries using non-contrast/non-gated Chest CT scans. It calculates the Agatston score for coronary artery calcification, segments and evaluates the right and left coronary arteries. It offers risk stratification based on calcium score, gender, and age, using percentile-based risk categories by established guidelines. Designed for healthcare professionals, it supports storing, transferring, inquiring, and displaying CT data sets on-premises, accessible via mobile devices and Chrome browsers. It is intended for adult patients over age 40 and use with General Electric CT equipment.
Technology
AVIEW CAC is a software installed on PCs that uses DICOM 3.0 standards to read, manipulate, analyze, and process chest CT images. It automatically segments coronary arteries from non-contrast/non-gated Chest CT scans and calculates calcium scores, including the Agatston score, volume score, and mass score. The device supports risk stratification using established guidelines and communicates with PACS. It is limited to GE CT scanner data and supports mobile and desktop access through browsers. The segmentation uses deep learning.
Performance
Performance testing involved nonclinical validation comparing coronary calcium scoring results from AVIEW CAC against ground truth and predicate devices using 150 gated coronary and 150 non-gated chest CT cases. The device demonstrated high intraclass correlation coefficients (>0.84) for total, left (LCA), and right coronary artery (RCA) calcium scoring, indicating reliable and accurate performance. Clinical studies were not required, as the indication and technology are substantially equivalent to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/28/2023
6 months - 2
FDA Approval
3/29/2024
Other devices from Coreline Soft Co., Ltd.
- AVIEW Lung Nodule CAD2023 • 510K
- AVIEW2022 • 510K
- AVIEW RT ACS2022 • 510K
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