Myocardial Strain Software Application
Circle Cardiovascular ImagingThe Myocardial Strain Software Application by Circle Cardiovascular Imaging is a software tool that analyzes cardiac MRI images to provide detailed measurements of heart muscle deformation. It helps clinicians assess myocardial function by computing metrics like strain, displacement, velocity, and torsion, supporting diagnostic decisions in patients with suspected heart disease.
Intended Use
Qualitative and quantitative evaluation of cardiovascular MR images in DICOM format, providing measurements of 2D LV myocardial function for diagnostic information in patients with suspected heart disease.
Technology
Software analyzes CMR images via 2D feature tracking on cine SSFP images using a nearly incompressible deformable model. It calculates various deformation metrics including strain, strain rate, displacement, velocity, and torsion in radial, circumferential, and longitudinal directions without the use of AI or machine learning.
Performance
The software underwent verification and validation testing per ISO and FDA guidance standards. Testing included the use of analytical and realistic phantoms, comparisons with manual expert tracking, and adherence to ISO 13485, IEC 62304, ISO 14971, and DICOM standards. No clinical studies were required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/31/2023
3 months - 2
FDA Approval
12/7/2023
Other devices from Circle Cardiovascular Imaging
- StrokeSENS ASPECTS Software Application2025 • 510K
- cvi42 Software Application2024 • 510K
- Cardiac CT Function Software Application2024 • 510K
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