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The R2 Breast Imaging Workstation is intended for the manipulation and display of x-ray images, including the primary reading of mammograms. It can show images from different acquisition/scanning devices and interfaces to various image storage and printing devices using DICOM or similar interface standards. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians and assistants. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

The R2 Breast Imaging Workstation is a combination of dedicated computer software and hardware. The workstation consists of a commercially available imaging workstation and the R2 plug-in software application, which is compatible with the workstation through a Clinical Application Interface (CAI).

The family of R2 Image Display Units with UDS software is intended to display low resolution, non-diagnostic medical images with annotations such as precomputed regions-of-interest or pre-computed CAD marks from medical scanning devices.

The R2 family of Image Display Units are a combination of dedicated computer software and hardware. The System uses an off-the-shelf personal computer with Windows-based CPUs, a hard drive, and various sizes of off the shelf monitors. Despite the variability in physical dimensions, all monitor display units have the identical functional specifications. R2 Uniform Image Display Software (UDS) is provided with all R2 image display units. This version of display software provides an updated user interface and CAD mark display features

The ImageChecker CT Software Package with Filling Defect Indicator (FDI) is used during the review of contrast-enhanced computed tomography (CT) images of the chest. This software tool enables the radiologist to view and analyze regions of the image containing low density within vascular structures that may be indicative of filling defects or other intravascular abnormalities. The software is designed to assist the radiologist in characterization and classification of these suspicious candidate thoracic abnormalities in terms of density, size, dimension, shape and position, thus aiding in the patient management care decision process.

The ImageChecker CT Software Package with Filling Defect Indicator (FDI), the subject of this notification, is a thoracic image visualization and analysis tool. This tool offers an extended functionality of the ImageChecker CT Workstation, utilizing segmentation techniques similar to the two above-mentioned predicates. Based on physician request, the FDI tool automatically segments locations in the vasculature of the chest containing low densities that typically correlate with filling defects. The process is based on simple segmentation methodology applied to contrast-opacified CT images of the chest segmentation methouorogy appels below a certain HU (Hounsfield Unit) threshold. fuentifying region is highlighted by placing a triangle on the region of the vascular structure of interest. This extended software functionality is designed for use with the structure of interesent on the R2 ImageChecker CT Workstation (K023003) and on other CT workstations that utilize the ImageChecker CT Workstation software tools. The FDI tool contains modifications to the Workstation with a special workflow based on automated segmentation for the visual identification of possible lung filling defects.

The Comprehensive Chest Analysis Tools (C-CAT) package consists of software that enables radiologists to view, analyze, register and compare new and previous series of thoracic CT images. The software package assists the radiologists by calculating volume change and doubling time of selected segmented candidate thoracic abnormalities, such as pulmonary and pleural nodules and lesions, found on these images. The software is designed to assist the radiologists in characterization and classification of these suspicious candidate thoracic abnormalities in terms of size, dimension, shape and position and thus aid in the patient management care decision process.

The C-CAT software is dedicated to assist the radiologist in assessing multiple CT case studies as well as any selected abnormal thoracic regions of interest (ROI's), such as pulmonary lesions, nodules, etc. It enables: - a) a detailed visualization and analysis of the CT slices using tools such as Multi-Planar Reformat and Sliding Maximum Image Projection; - b) a comparative analysis of the aligned, simultaneously presented current and previous CT images with findings and selected ROIs with their size (volumetric and diameter) measurement displayed for assessment of volume change and doubling time; and - c) review of software-generated comparative reports that present information such as development of new lesions, prior lesion's progression and doubling time. This software tools package is designed for use with the ImageChecker CT Workstation (K023003, cleared 11/20/02) and other CT workstations that utilize the ImageChecker CT Workstation software tools.

The ImageChecker-CT is indicated for use as a general imaging workstation, and is intended to be used to acquire, store, transmit and display images from medical scanning devices. Specific indications for use for the ImageChecker-CT Workstation are the display of a composite view of 2D cross-sections, and 3D volumes of chest CT images, including findings or regions of interest ("ROI") identified by the radiologist or Computer Assisted Detection ("CAD") findings. The general indications for use of the ImageChecker-CT Workstation are as a general imaging workstation to assist radiologists in reviewing digital computed Tomography (CT) images of the chest. Specific indications for use for the ImageChecker-CT Workstation are the display of a composite view of 2D cross-sections, and 3D volumes of chest CT images, including findings or regions of interest ("ROI") identified by the radiologist or Computer Assisted Detection ("CAD") findings.

The ImageChecker-CT System is a combination of dedicated computer software and hardware. The System uses an off-the-shelf personal computer with Windows and Linux-based CPUs, a hard drive, and a single monitor.