cvi42 Software Application
Circle Cardiovascular Imaging Inc.cvi42 Software Application is a medical imaging software developed by Circle Cardiovascular Imaging Inc. that supports clinicians by enabling viewing, post-processing, and quantitative analysis of cardiovascular magnetic resonance (MR) and computed tomography (CT) images. It uses semi-automated machine learning algorithms to assist in measuring cardiac function, vessel characteristics, and calcified plaques, helping medical professionals in diagnostic decision-making related to heart and adjacent vessels.
Intended Use
cvi42 is intended to be used by qualified medical professionals for viewing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images and cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine Standard format, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.
Technology
cvi42 is software as a medical device (SaMD) that combines digital image processing, visualization, quantification, and reporting tools with machine learning techniques for semi-automatic contouring and analysis of cardiovascular MR and CT images. It accepts DICOM format images from various acquisition equipment without direct interface, enabling measurements such as volume, mass, velocity, strain, and calcium scoring alongside standard visualization tools like MPR, MIP, volume rendering and bone removal.
Performance
Performance testing includes ISO 13485:2016 and FDA Guidance-compliant verification and validation with unit and system tests, plus clinical phantom and imaging dataset validation. Machine learning algorithms were trained and validated on multi-vendor MR and CT images with diverse population data. Testing covered accuracy of segmentation, classification, and quantitative metrics such as strain measurements and calcium scoring. Testing results met pre-defined acceptance criteria including measurement accuracy and classification performance across various cardiac functions and plaque analysis.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/16/2024
29 days - 2
FDA Approval
10/15/2024
Other devices from Circle Cardiovascular Imaging Inc.
- StrokeSENS ASPECTS Software Application2025 • 510K
- Cardiac CT Function Software Application2024 • 510K
- Myocardial Strain Software Application2023 • 510K
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