DEVICE: Registration Marker Kit, Sterile, Single (00850044606016)

A non-powered, noninvasive device intended to provide a fixed reference point for the electromagnetic (EM) tracking of a patient and/or instruments during a surgically-invasive procedure, whereby tracking images are overlaid on pre-acquired and/or real-time images [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US)]. Also referred to as a navigation fiducial marker or tracker, it typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an EM sensor for active registration. This is a single-use device.

An assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].