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The Nurochek System is intended for prescription use in healthcare facilities or clinical research environments for subjects ages 14 years and older. The Nurochek System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display and store electroencephalograms (EEGs) during the generation of VEPs. The Nurochek System only acquires and displays physiological signals: no claims are being made for use as a diagnostic criterion or for the analysis of the acquired signals with respect to the accuracy, precision and reliability.

The Nurochek System combines hardware, firmware and software to generate and acquire physiological signals, specifically, VEPs. These VEPs are generated by a visual stimulus delivered through the Nurochek headset worn by the subject. This visual stimulus is a short-duration flash of white light. The Nurochek headset acquires the VEPs from the rear of the head and transmits the resulting EEG to the Nurochek software application to be displayed to the user and stored. These acquired signals are intended to be analyzed by a Physician. The Nurochek System operates on the principles of generating VEPs via photic simulation and acquiring the VEPs via EEG. Photic stimulation is provided through short-duration flashes of white light from multiple LEDs located in the front of the headset to direct the stimulus into the subject's eyes. The VEPs are acquired by an EEG comprising of a total of 5 electrode interfaces with hydrophilic foam cylinders saturated with saline solution to provide electrical contact to the subject's scalp. A Bluetooth receiver and transmitter located within the Nurochek headset allows it to communicate with and be controlled by the Nurochek software application. The Nurochek software application provides a graphical user interface which allows: Collection of the subject details and consent, Initiation of a study and tracking of patient information, Acquisition and transmission of signals wirelessly to and from the headset, Display of the contact quality of electrodes to the subject's scalp, Recording, processing and display of EEG signals received from the headset, and Manage previous EEG recordings of VEPs.

The Precision Screw is intended for establishing fixed reference point(s) in patients undergoing Stereotactic Surgery for procedures in the cortical bone of the vertebrae. The Precision Screw can be used as an accessory with frameless navigation systems.

The Precision Screw is a self-drilling metallic fixation device used only as a reference point during stereotactic procedures. Commonly known as a Fiducial Screw or a stereotaxic instrument, the Precision Screw can be used as an accessory with frameless navigation systems, as appropriate, from other manufacturers.