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BU-CAD is a software application indicated to assist trained interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions suspicious for breast cancer who are being referred for further diagnostic ultrasound examination. Output of the device includes regions of interest (ROIs) and lesion contours placed on breast ultrasound images assisting physicians to identify suspicious soft tissue lesions from up to two orthogonal views of a single lesion, and region-based analysis of lesion malignancy upon the physician's query. The region-based analysis indicates the score of lesion characteristics (SLC), and corresponding BI-RADS categories in user-selected ROIs or ROIs automatically identified by the software. In addition, BU-CAD also automatically classifies lesion shape, orientation, margin, echo pattern, and posterior features according to BI-RADS descriptors. BU-CAD may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report (SR). Patient management decisions should not be made solely on the basis of analysis by BU-CAD. Limitations: BU-CAD is not to be used on sites of post-surgical excision, or images with Doppler, elastography, or other overlays present in them. BU-CAD is not intended for the primary interpretation of digital mammography images. BU-CAD is not intended for use on mobile devices.

BU-CAD developed by TaiHao Medical Inc. is a software system designed to assist users in analyzing breast ultrasound images including identification of regions suspicious for breast cancer and assessment of their malignancy. The system consists of a Viewer, a Lesion Identification Module, and a Lesion Analysis Module. The Viewer loads breast ultrasound and mammography images from local storage or PACS for review, and includes tools for measurement and image adjustment. The Lesion Identification Module identifies automated ROIs and generates lesion contours on breast ultrasound images. The Lesion Analysis Module analyzes given ROIs and generates a score of lesion characteristics (SLC), BI-RADS category, and BI-RADS descriptors. Users can replace automated ROIs with re-delineated rectangular ROIs for analysis. The last analysis results are displayed and modifiable by the user. BU-CAD also supports exporting CAD results to third-party reporting software.

BR-FHUS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with manipulation and analysis tools in reviewing breast ultrasound images. Images and data are previously recorded from various imaging systems and other sources such as calibrated spatial positioning devices. BR-FHUS Viewer 1.0 provides the capability to visualize two-dimensional ultrasound images along with the scanning paths and position information of probe that stored in the DICOM file in advance.

BR-FHUS Viewer 1.0 is an electronic image review and reporting software program intended to operate on a windows-based computer. The device allows the review of previously recorded ultrasound examinations, which are performed using standard ultrasound systems and other sources such as calibrated spatial positioning devices, the images of which were recorded digitally. The images are displayed on a computer monitor. The images can be reviewed individually or as a self-playing sequence. The software can adjust the speed of the playback. In addition, the device software allows the user to save the screenshots as DIOM-compatible files and generate electronic reports.

BR-FHUS Navigation 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with tools for electromagnetic tracking of instruments in respect of breast ultrasound images generated from FDA cleared handheld ultrasound devices. The device is not intended to be used in the environment of strong magnetic or electromagnetic fields, such as in Magnetic Resonance Imaging (MRI) room. BR-FHUS Navigation 1.0 is indicated for use as an adjunct to handheld breast ultrasound to assist the physicians in their scanning process. The scanning paths are displayed on a route map and provide quality control of scanning to provide an overall observation of scanning process.

BR-FHUS Navigation 1.0 is a standalone software device installed on a standalone windows-based computer. It requires an off-the-shelf PC computer, computer user interface (keyboard, mouse, display), off-the-shelf image capture device (PCI frame grabber card or USB frame grabber device), and an off-the-shelf 3D electromagnetic tracking system (Ascension Technologies). The system includes software for Position Sensor Monitoring, Image presentation and recording, and user interface, and hardware including a Position Sensor Clip (electromagnetic), Sensor Transmitter, and Control Computer.

BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software device is indicated for use to assist the physicians in their review and analysis of the 3-D breast ultrasound images generated by ABVS.

BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software also automatically generates reports to provide the sub-image and location information of markers annotated during the image review.