CVI42 is a software tool designed for analyzing CT and MR images of blood vessels. It provides tools for image visualization, processing, vessel centerline and lumen calculations, stenosis evaluation, and lesion characterization. This helps physicians evaluate and track vascular lesions more effectively for improved patient diagnosis and management.
Intended Use
Image analysis software package add-on for evaluating CT and MR images of blood vessels to support diagnostic decision making regarding vascular lesions.
Technology
Software employing digital image processing and visualization tools such as multiplanar reconstruction, maximum intensity projection, volume rendering, centerline calculation, lumen and stenosis calculation, lesion reporting and image manipulation to assist physicians in vascular lesion analysis on CT and MR images.
Performance
Testing was performed according to a Master Software Test Plan, integrated with the company's software development process.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/4/2014
2 months - 2
FDA Approval
8/22/2014
Other devices from CIRCLE CARDIOVASCULAR IMAGING INC
- StrokeSENS ASPECTS Software Application2025 • 510K
- cvi42 Software Application2024 • 510K
- Cardiac CT Function Software Application2024 • 510K
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