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The XV Ventilation Lung Analysis Software is software-based image processing technology that analyzes cinefluorograph images and a CT (can be a previously acquired CT that is representative of the patient's present lung envelope), to quantify ventilation of pulmonary tissue for use in adult patients. The XV Ventilation Lung Analysis Software provides reproducible quantification for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. For use by referral from a pulmonary specialist or equivalent, the Device can be used to provide the physician with additional clinical data in the diagnosis and documentation of inhomogeneties and defects in pulmonary ventilation. Quantification and statistics are provided in the form of a Report, including: - · The tidal volume (i.e. total lung ventilation), presented as a single value; - · Visualization of lung ventilation with color-defined specific ventilation ranges overlaid on the CT slices; - · The heterogeneity of lung ventilation, presented as three values, which quantifies the regional variability of the ventilation: and · Ventilation graph/ histogram of the classified lung voxel's relative frequencies showing the frequency distribution of regional specific ventilation measured across the entire lung, including ventilation defect percentage which shows the volume of lung with low ventilation. The clinical study used to validate the Device was limited to patients selected to undergo Radiation Therapy (most commonly for breast cancer and esophageal cancer). In this study these patients were examined using the Device at four time-points over a 13-month period (twice prior and twice following radiation therapy).

The XV Lung Ventilation Analysis Software is a software-based image processing technology that analyzes cinefluorograph images in combination with a CT image to quantify ventilation of pulmonary tissue, thereby providing support to physicians in their assessment of patients with lung diseases. The XV Lung Ventilation Analysis Software measures the tissue motion of the lung, at all locations throughout the lung, and at all phases of the breath. It uses these motion measurements to calculate the 4-dimensional (4D) ventilation of lung tissues. Quantification and statistics are provided in the form of a Report. The key outputs are: - The tidal volume (i.e. total lung ventilation), presented as a single value; - Visualization of lung ventilation with color-defined specific ventilation ranges; . - The heterogeneity of lung ventilation, presented as three values; and . - . Ventilation graph/ histogram of the classified lung voxel's relative frequencies including ventilation defect percentage.