cvi42 Auto Imaging Software Application
Circle Cardiovascular Imaging Inccvi42 Auto Imaging Software Application is an AI-powered medical imaging software designed to assist clinicians in evaluating cardiovascular MR and CT images. It uses machine learning to semi-automatically contour cardiac structures, perform calcium scoring, and analyze coronary arteries, aiding in diagnosis and quantitative assessment of heart and vessel conditions.
Intended Use
cvi42 Auto is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels; perform calcium scoring; and to confirm the presence or absence of physician-identified lesion in blood vessels. The target population for cvi42 Auto's manual workflows is not restricted; however, cvi42 Auto's semi-automated machine learning algorithms are intended for an adult population. cvi42 Auto shall be used only for cardiac images acquired from an MR or CT scanner. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR or CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.
Technology
cvi42 Auto is a software as a medical device (SaMD) combining digital image processing, visualization, quantification, and reporting tools. It uses machine learning algorithms trained on diverse clinical data for semi-automatic segmentation of the four heart chambers in MR images, calcium scoring using pixel intensity on CT images, and semi-automatic coronary artery centerline placement on CT images. It supports 2D and 3D visualization and operates independently of image acquisition equipment.
Performance
Performance testing included validation of machine learning derived outputs on 235 anonymized patient images from multiple manufacturers and clinical sites. MR function analysis achieved 97%-100% classification accuracy with volume prediction errors between 5%-10%. Calcium scoring classification accuracy ranged from 86%-99%. Coronary artery centerline detection showed 82%-94% performance. All results met pre-defined acceptance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/21/2021
7 months - 2
FDA Approval
7/28/2022
Other devices from Circle Cardiovascular Imaging Inc
- StrokeSENS ASPECTS Software Application2025 • 510K
- cvi42 Software Application2024 • 510K
- Cardiac CT Function Software Application2024 • 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.