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The ISEN-Goggles with Data Viewer are used in the assessment of nystagmus by measuring, displaying, and analyzing eye movements.

This device consists of patient eye goggles ("ISEN-Goggles"), previously cleared under K152727, and a software application for data visualization and analysis ("Data Viewer"). The ISEN-Goggles have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USB port to facilitate transfer of data captured and stored in the device's SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for nearsimultaneous viewing of the video images from both eyes on the attached LCD screen. The Data Viewer software retrieves data from the goggles, displays it, performs analysis functions, and exports customizable reports. It includes a patient database.