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The Thora-3Di is intended for a one-time measurement of respiratory rate as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider. The Thora-3Di is not intended to monitor vital signs. This device is not an apnea monitor.

The Thora-3Di uses Structured Light Plethysmography (SLP) to derive respiratory rate. With the Thora-3Di, a structured grid pattern of light is projected onto the thoracoabdominal wall and two digital video cameras record changes in the grid pattern due to movement of the wall. A dedicated parallel processor executes real-time pattern recognition algorithms to identify the position of each part of the virtual grid in each camera. The system computes the 3-dimensional coordinates of the different markers to assess respiratory rate. The Thora-3Di does not include any wireless transmission features, nor does it include a cloud or other remote functionality (no cybersecurity-related features).