Cardiac CT Function Software Application
Circle Cardiovascular ImagingThe Cardiac CT Function Software Application by Circle Cardiovascular Imaging is a software tool that assists medical professionals in analyzing cardiac function from multi-phase, multi-slice cardiovascular CT angiography images. It uses AI to segment cardiac structures and compute key function metrics such as volume and ejection fraction, helping clinicians evaluate heart function more accurately and efficiently.
Intended Use
The Cardiac CT Function Software Application is intended for qualitative and quantitative evaluation of cardiovascular CT images in a DICOM Standard format, to calculate and display cardiac function metrics such as end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, and LV myocardial mass.
Technology
Software device that analyzes cardiac CT images using AI/ML algorithms to detect and segment heart chambers (LV, RV) and calculate cardiac metrics. It provides manual and semi-automatic segmentation, 2D/3D visualization, and multiplanar reconstruction of the original CT data.
Performance
Performance testing verified compliance with design requirements and FDA guidances. ML algorithms were trained and validated on diverse clinical data from multiple vendors and sites, showing segmentation accuracy with Dice coefficients above 82%, low mean absolute volume errors, and ejection fraction bias within acceptable limits compared to expert readers.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/16/2024
1 month - 2
FDA Approval
6/7/2024
Other devices from Circle Cardiovascular Imaging
- StrokeSENS ASPECTS Software Application2025 • 510K
- cvi42 Software Application2024 • 510K
- Myocardial Strain Software Application2023 • 510K
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