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The Tractus TissueMapper Image Recording System is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

The TissueMapper Image Recording System is an electronic image recording and storage system. The device is an accessory to standard ultrasound systems and allows the digital recording images from those standard ultrasound devices, along with the spatial position coordinates of the recorded images. The images are recorded from the video out port of the standard ultrasound device. The images are recorded as output from the video output of the standard ultrasound imaging device. Brightness, contrast, and gamma are not adjusted by the program. lmages are recorded using Video Graphics Array (VGA) or Digital Video Interface (DVI) video output formats. Images are displayed and saved as uncompressed, 8-bit grayscale images. No loss of data occurs with this image format. The Imaging probe location is monitored and location identifiers are stored with each recorded image. Magnetic location sensors are attached to the hand-held ultrasound imaging probe via a clip.

The Tractus TissueMapper Reviewer Application provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. The supported imaging modality is Ultrasound (US). Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices. This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to imaging probes or other tracked devices. This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures, including head and neck, breast, thoracic, and abdominal applications.

The TissueMapper Reviewer Application is an electronic image review and reporting software program intended to operate on a Windows Operating System (OS) 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 may be reviewed individually or as a self-playing sequence (video clip). Certain image functions may be adjusted by the software, such as image brightness, image contrast and image size magnification or reduction. The speed of the video presentation may be adjusted by the software. The device software presents sequences of mapped ultrasound images to review previously-recorded hand-held ultrasound examinations, which can be transferred to a computer using a media storage device (USB). Each image is mapped anatomically with respect to a user-identified anatomical landmark, such as the nipple or navel. The image mapping information allows anatomic location of useridentified regions of interest for comparison with other imaging techniques or for procedure planning purposes. The device software allows the user to measure the size, on two user-defined axes, of the region of interest. The device software allows the user to create and store electronic reports on each region of interest.