Vitrea CT VScore
Canon Medical Informatics, Inc.Vitrea CT VScore is a software application designed to aid medical professionals in visualizing, segmenting, and quantifying calcified lesions in ECG-gated cardiac CT images of patients aged 30 years or older. It provides calcium scoring and generates detailed reports to assist clinicians in cardiac imaging assessment.
Intended Use
The Vitrea CT VScore option is a calcium scoring application intended for the visualization, evaluation, and documentation of calcified lesions on non-contrast ECG-gated, cardiac CT DICOM images for patients aged 30 years or older.
Technology
The device is a software application running on the Vitrea Advanced Visualization platform, allowing users to segment calcified lesions, categorize them, calculate Agatston and volume calcium scores, and generate reports including DICOM structured reporting objects. It does not have hardware components and processes standard DICOM CT images as input.
Performance
Cybersecurity testing showed a robust security posture, exceeding the predicate. DICOM SR testing verified correct clinical information representation and interoperability, indicating no negative impact on safety or effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/10/2024
6 months - 2
FDA Approval
4/10/2025
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