Vitrea CT VScore

Vitrea CT VScore is a software application for visualizing, evaluating, and documenting calcified lesions in cardiac CT images for patients aged 30 years or older. It allows users to segment and categorize calcified lesions, calculate calcium scores (Agatston and volume), and generate reports. The application is intended for use by qualified medical professionals to assist physicians in medical imaging assessment.

The device offers updated cybersecurity controls and documentation compliant with FDA's September 2023 software cybersecurity guidance. It adds DICOM structured reporting (SR) objects for standardized clinical reporting. The core calcium scoring algorithms remain similar to the predicate device.

Not stated in this summary. The document references FDA guidance on cybersecurity in medical devices but does not cite specific ISO, IEC, or ASTM standards.

The device performs the same intended function as the predicate (calcium scoring on cardiac CT images) with substantially similar technological characteristics. The two key differences—enhanced cybersecurity controls and DICOM SR capability—do not alter the device's fundamental safety or effectiveness; nonclinical testing confirmed cybersecurity robustness and that DICOM SR output correctly represents clinical information and integrates with other systems without negatively impacting device performance.