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The Spine Navigation system is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the sacro-lumbar region. The headset of the Spine Navigation system displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The Medivis Spine Navigation System is an image-guided navigation system designed to assist surgeons in placing pedicle screws accurately during spinal surgery. The Medivis Spine Navigation System is comprised of software, a head-mounted display (HMD), passive reflective markers and reusable components. The device provides various image display options and manipulation features, primarily controlled through the touchscreen monitor. An HMD serves as an adjunct display and functions as an optical 3D tracking component for patient and surgical tool localization. The device registers patient data to the surgical environment through IR tracking.

SurgicalAR is a software device for display of medical images and other healthcare data. It includes functions for image review image manipulation, basic measurements and 3D visualizations and 3D volume rendering). Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. SurgicalAR software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians and technologists. When accessing SurgicalAR software from a wireless stereoscopic head-mounted display (HMD) or mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

SurgicalAR is a software platform to be used by clinicians for the visualization of medical images in 3D to allow for surgical planning activities. The device takes pre-acquired 2D medical images and reconstructs 3D models that a clinician can then view on a stereoscopic, holographic display. The software application is used to: • Load patient CT/MR DICOM data • View DICOM data using a traditional computer monitor or in Augmented Reality (AR) using a head-mounted display, HMD.