(182 days)
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. The application allows the user to segment and categorize the calcified lesions and calculate the calcium scores. The user can create a report including the data, images, literature, and additional relevant information. The application is intended to be used by qualified medical professionals to assist the physician in medical imaging assessment based on their professional judgment and other patient information. The calcification segmentation map is intended for informational use only.
The Vitrea CT VScore™ option is a calcium scoring application intended for the visualization, evaluation, and documentation of calcified lesions on cardiac CT images for patients aged 30 years or older.
The application allows the user to segment and categorize calcified lesions and calculate the calcium scores. The user can create a report including the data, images, literature, and additional relevant information. The application is intended to be used by qualified medical professionals to assist the physician in medical imaging assessment based on their professional judgment and other patient information.
The Vitrea CT VScore™ option is an interactive user-driven application. The application allows users to perform visualization, quantification and documentation of calcium lesions on cardiac CT studies.
The application provides a user interface with the following main functions:
- Allows manual selection of calcified lesions that meet selection criteria such a 3-pixel threshold and a 130 HU density threshold.
- Allows users to manually assign the selected calcium to the appropriate coronary and non-coronary categories.
- For selected calcium, calculates Agatston and volume scores.
- Allows users to select well-established, standard population databases and risk categories, along with literature references, to include in reports.
- Allows users to output documentation using standard DICOM objects (such as DICOM structured reporting objects).
The application takes standard DICOM images generated by CT scanners as input and provides a user interface permitting users to create the desired outputs as part of their clinical workflow. The device returns Agatston and volume calcium scores; well-established methods of calculation exist for these scores. Optionally, and for reporting purposes, the device displays patient scores in the context of well-established population reference databases and calcium scoring reporting systems.
The application is intended to operate on cardiac CT images. The device is indicated for patients aged 30 or above.
The device is Software as a Medical Device (SaMD) and has no hardware or material components.
The device is a software application that runs on the Vitrea Advanced Visualization platform. The device operates on cardiac CT DICOM images of a patient after they have been acquired. The device produces DICOM output, including DICOM SR objects.
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§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.