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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