HealthCCSng
Zebra Medical Vision Ltd.HealthCCSng is a software device that automatically analyzes non-cardiac-gated CT scans to estimate the amount of calcified plaque in coronary arteries, which can indicate coronary artery disease risk. It provides radiologists with calcium detection categories and annotated images to aid in clinical decision-making within their usual workflow.
Intended Use
HealthCCSng is intended as a non-invasive post-processing software to evaluate calcified plaques in coronary arteries from non-cardiac-gated CT scans of adults over 30, providing an estimated coronary artery calcium detection category for informational purposes integrated to radiologist workflow.
Technology
HealthCCSng uses an AI algorithm to automatically detect and quantify coronary calcium on existing non-cardiac-gated adult CT scans by analyzing image data, validating study compatibility, and generating a three-category output for calcium amount with visual annotations. It integrates into Zebra's Imaging Analytics Platform and supports radiologist review as an adjunct tool.
Performance
HealthCCSng was clinically validated retrospectively on 447 anonymized non-cardiac-gated chest CT cases from multiple sites, showing 92.5% overall agreement with ground truth coronary calcium categories established by radiologist consensus, exceeding predicate device performance and meeting safety and effectiveness criteria across imaging parameter subsets.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/13/2021
8 months - 2
FDA Approval
9/15/2021
Other devices from Zebra Medical Vision Ltd.
- HealthPPT2021 • 510K
- HealthJOINT2020 • 510K
- HealthMammo2020 • 510K
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