Electromagnetic/optical surgical navigation device tracking system

Intended purpose

The device is a software enabling computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively. The software is part of a system intended to be used for intraoperative image-guided localization to enable open and minimally invasive surgery. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image data based model of the anatomy.