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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.

Open Rib is image analysis software for chest CT images. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.

Open Rib is image analysis software for chest CT images. The software resides on the Vitrea Advanced Visualization (AV) platform. Open Rib offers a visualization of the unfolded rib cage called an "unfolded cylindrical projection" (UCP) that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventual multiplanar reformat views. Open Rib offers geometric and HU measurement tools. The images can be directly exported to PACS and batch saved.

Vitrea® Coronary Artery Analysis (CT Cardiac Analysis) is intended for investigating coronary obstructive disease by providing a non-invasive survey of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the vessel. The clinician can semi automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit statistics.

This submission is for the addition of a new feature, the Multi-Vessel preset, to the Vitrea CT Cardiac Analysis application. This application was originally cleared as "CT Coronary Analysis" in the predicate submission K052632 Witreal Image Processing Software). The application resides on the Vitrea AV platform, most recently cleared as K172855 (Vitrea Advanced Visualization, Version 7.6). The submission is also intended to notify the Agency of the following non-significant changes to the previous clearance, documented by Letters to File (LTF): · Vessel Tracking for Low kV Scans · Angiographic View The previously cleared Vitea CT Cardiac Analysis option (cleared in the predicate submission K052632 under the name "CT Coronary Analysis") provides a variety of tools and vith clinical CT images of the coronary arteries, heart, and surrounding tisse. The software supports CTA studies acquired by 4-slice and above multislice CT scanners, and includes the following features: - · Automatic segmentation of the heart from the rest of the anatomy - · Zero-click coronary vessel tree segmentation and automatic labeling of the three main coronary arteries - · Selection of any coronary artery for viewing with the Vessel Probe tool with easy centerline review and editing - · Full Vessel Probe capabilities for coronary arteries including the Lesion Tool, Vessel Walk, and Cath View · A flythrough preset configured for flying through the coronary vessels (Global Illumination Rendering not available in the flythrough view) - Unique Heart Mode to automatically orient oblique MPR views to show one short-axis view and two long-axis views - · Key findings classification during reading of the study for semi-automated structured report generation - · Measurement of plaque burden between the lumen and the outer wall with the SUREPlaque tool - · Display of a Transluminal Attenuation Gradient for probed vessels. This submission adds the new Multi-Vessel preset feature. Whereas the offered initial automated probing and labeling of the three main coronary arteries, the new feature adds an additional initial automated probing (without labeling) of up to seventeen additional vessels in the vessel trees associated with the main coronary arterior tree, the left circumflex artery (LCX) tree, and the right coronary artery (RCA) tree. The tree structure allows edits to the trunk to be reflected on all the branch vessels. In both the subject and the predicate devices, the user has the ability to manually probe an unlimited number of additional vessels. The capability of either manually or automatically "probing" vessels was present in the predicate software.