AVIEW CAC
Coreline Soft Co., Ltd.AVIEW CAC is a software tool designed for healthcare professionals to analyze non-contrast, non-gated Chest CT scans and quantitatively evaluate calcified plaques in coronary arteries. It automatically calculates the Agatston score, segments and evaluates the coronary arteries, and provides risk stratification based on calcium score, gender, and age. It facilitates access to CT data on various platforms, helping clinicians assess coronary artery disease risk using existing CT images.
Intended Use
AVIEW CAC provides quantitative analysis of calcified plaques in the coronary arteries using non-contrast/non-gated Chest CT scans, calculates the Agatston score for coronary artery calcification, segments and evaluates right and left coronary arteries, and provides risk stratification based on calcium score, gender, and age with percentile-based risk categories by established guidelines. The device supports storing, transferring, inquiring and displaying CT datasets on-premises and access via mobile devices and Chrome browsers. It analyzes existing non-contrast/non-gated Chest CT studies including the heart of adult patients over 40 years old. The device is limited to CT scans acquired on GE or its subsidiaries equipment. Use with CT scans from other manufacturers is not validated or recommended.
Technology
AVIEW CAC is a software product installed on a PC that reads, manipulates, analyzes, post-processes, saves, and sends images using DICOM 3.0 standard. It performs quantitative analysis of CT scans by automatically analyzing coronary arteries and calculating calcium scores. It supports functions such as storing, transferring, and displaying CT data sets. Compared to the predicate device, it includes enhancements like UI changes, a summary page, and a function to calculate arterial age based on Agatston score.
Performance
No clinical study was necessary due to the device not being new and having indications for use equivalent to the predicate device. The device's safety and effectiveness were supported by non-clinical testing including software verification and validation. The device is substantially equivalent to the predicate device in technical characteristics, functions, applications, and intended use without introducing new scientific technology.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/29/2024
2 months - 2
FDA Approval
2/14/2025
Other devices from Coreline Soft Co., Ltd.
- AVIEW2025 • 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.