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SoftVue™ is indicated for use as a B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning curvilinear array transducer. The device is not intended to be used as a replacement for screening mammography.

SoftVue™ is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast using a curvilinear array transducer that completely surrounds the breast. The modification of SoftVue™ will allow the system to generate colorized and grayscale relative stiffness ultrasound images in addition to the grayscale B-mode images generated by the unmodified SoftVue™ system. This new feature will allow the user to be able to determine whether a region of interest is harder or softer than the surrounding tissue. No clinical diagnostic claims are being made. SoftVue™ is comprised of the following subsystems: the Transducer, Table/Housing Assembly, Water Conditioning System, Computer Control System, Image Reconstruction System, Power System, and the Data Acquisition System. Soft Vue™ has a built-in curvilinear transducer that is used to acquire ultrasound data. Data are acquired from a patient lying prone on the table with their breast submerged in an imaging chamber filled with warm (body temperature) water. The breast is positioned in the center of the transducer. A camera, located at the bottom of the imaging chamber provides a live video feed to the system operator to aid in positioning the patient's breast. Once the scan is initiated, the transducer collects data that are processed to produce a series of B-mode ultrasound image slices that can be stacked to yield a volumetric ultrasound image of the breast. Soft Vue™ also outputs colorized and grayscale relative stiffness image stacks that provide the radiologist with additional reference information. The Water Control System is used to de-gas and warm the water that is used as the image acquisition medium. The Computer Control System controls all of the functionality of the other subsystems. The reconstruction engine processes the image data acquired by the transducer ring into B-mode ultrasound images. The system includes a barcode reader and a touchscreen display (user interface). The touchscreen display allows the user to perform an imaging procedure. Patient information is entered into the system using either the QWERTY keyboard on the touchscreen display, using the barcode reader, or the user can import the patient information from a DICOM modality worklist on an externally networked RIS server. Device errors and warnings are displayed on the touchscreen display. SoftVue™ outputs the images to an externally networked PACS server which allows the images to be stored until they are reviewed on a workstation.

SoftVue™ is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning curvilinear array transducer. The device is not intended to be used as a replacement for screening mammography.

Soft Vue is an automated tomographic B-mode diagnostic ultrasound system to be used as an adjunct to mammography for imaging a patient's breast. SoftVue is comprised of the following subsystems: the Transducer. Table/Housing. Water Control System, Computer Control System, Image Reconstruction System, Power System, and the Data Acquisition System. SoftVue has a built-in curvilinear transducer that is used to acquire ultrasound images. Images are acquired from a patient lying prone on the table with their breast submerged in an imaging chamber filled with warm (body temperature) water. The breast is positioned in the center of the transducer. A camera, located at the bottom of the imaging chamber provides a live video feed to the system operator to aid in positioning the patient's breast. Once the scan is initiated. the transducer collects data that are processed to produce a series of ultrasound image slices that can be stacked to yield a volumetric ultrasound image of the breast, The Water Control System is used to de-gas and warm the water that is used as the image acquisition medium. The Computer Control System controls all of the functionality of the other subsystems. The reconstruction engine processes the image data acquired by the transducer ring into B-mode ultrasound images. The system includes a barcode reader, touchscreen console (user interface), and display monitor. The touchscreen console and monitor allow the clinical user to perform an imaging procedure on a patient. Patient information is entered into the system using either the touchscreen console or the barcode reader. Device errors and warnings are displayed on the console and/or display. Soft Vue outputs the image Storage Medium that allows the images to be stored until they are reviewed on a workstation or transferred via DICOM to a PACS environment.