Search Results

The UC-CARE NaviGo™ Workstation is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. Additional software features to assist biopsy procedures include patient data management, multi-planar reconstruction, segmentation, image measurementand 3-D image registration.

The device is specifically indicated to provide information on regional orientation within the prostate to assist biopsy procedures under standard ultrasound guidance, reconstruction of a 3D rendered surface model of the prostate and to display locations for biopsies that have been selected by the physician, as well as storage and future retrieval of this information.

The Navigo™ Workstation is an aiding tool in the management of prostate procedures. The Navigo™ Workstation is designed to assist the physician to transfer and display ultrasound images on the workstation screen, build, display, and manipulate a 3D model of the prostate on screen, provide regional orientation, archive the images and the 3D model, as well as provide data management solutions. The Navigo™ Workstation enables tracking, displaying and recording of the biopsy needle trajectory location retrieved from the ultrasound probe.

The Navigo™ Workstation is designed to work with standard transrectal Ultrasound system without changing or interfering with the physician's flow of work. The Navigo™ Workstation connects to the Ultrasound system and by tracking the Ultrasound probe's position, the recorded 2D Ultrasound images are transferred to the Navigo™ Workstation for viewing and 3D modeling.

The 2D images and the 3D model of the prostate are displayed on the Workstation screen. The workstation is equipped with tools to manipulate (rotate, zoom, pan) the model, to add planned biopsy locations on the model and to archive and retrieve the information for further use.

Pathology diagnosis results can be updated on the 3D model and a color display representation gives a visualized status of the prostate.

I am sorry but the provided text only contains regulatory information about the NaviGo™ Workstation, including its intended use, device description, and substantial equivalence to a predicate device. It does not include information about specific acceptance criteria or a study design to prove the device meets these criteria. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

Ask a specific question about this device