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With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.

Klarity SGRT system offers a dedicated non-irradiating and non-invasive surface guided radiation therapy solution. SGRT system includes three main application modules: patient positioning, treatment (motion) monitoring and respiratory gating. With the patient positioning module, the SGRT system continuously senses the 3D patient body surface and compares it with the prerecorded reference surface by 3D image registration: The calculated 6 degree-of-freedom positioning deviations are visualized and sent to the positioning couch, to ensure a consistent and efficient inter-session patient setup/positioning, both manually and automated. With the treatment (motion) monitoring module, the SGRT system monitors the patient's surface in real-time throughout the treatment session. Once the body part surface exceeds the predefined tolerance, the system will automatically alert the therapist and turnoff the beam immediately. With the respiratory gating module, the system keeps tracking the patient's respiratory movements in real-time. During the treatment delivery, this functionality is used to maximize the protection of organs-at-risk; And in CT room, this functionality is used to make the 4DCT imaging best adapt to the patient's breathing in order to minimize the 4DCT imaging artifacts caused by the respiratory motion. Klarity SGRT system mainly consists of advanced software. PC workstation, one or three 3D cameras and calibration tools. SGRT system provides two models, ARSG-E1A and ARSG-E3A.

1. Klarity SRS Baseplate: The device is indicated to position and/or immobilize adult and pediatric patients undergoing photon and electron radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the patient and enabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning, repositioning and immobilization. The Klarity SRS Basplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy. 2. Klarity Promise Baseplate: The device is indicated to position and or immobilize adult and pediativ undergoing proton radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the pabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning and immobilization. The Klarity Promise Baseplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

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Klarity Bolus is indicated for radiation therapy clinical treatments as a tissue equivalent aid to correct for anatomical irregularities and deliver a prescribed dose to the skin and underlying tissue. Target population is Adult, Child and Infant, and Federal (USA) law restricts this device to sale by, or on the order of a physician. Klarity Bolus has been tested for tissue equivalency at 6 MV and 10 MV photon and at 6 MeV electron energy levels. Further testing will be required to confirm performance with proton therapy systems.

Klarity Bolus is a moldable gel sheet material to be used by trained radiation therapy professionals as an aid to radiation treatment of uneven areas of a patient, such as at the nose or ears, to make up for missing tissue, or to provide build-up of radiation dose to the skin surface. The use of bolus is decided by a doctor or professional on a case by case basis, deciding if bolus is needed or appropriate, and deciding the amount and shape of the bolus material to be used. During radiation therapy treatments there can often be a "build up" of radiation dose a few millimeters beneath the surface of a patient's skin. Bolus material can be used to create a simulated layer of tissue that will raise the depth of the "build up" to be closer to actual skin level. This can benefit the accuracy and dose level for treating a skin cancer, for example. Bolus materials have been used for this purpose for many years. Klarity Bolus is provided as a non-sterile 30x30cm sheet in various thicknesses from 0.5cm to 4cm. Klarity Bolus incorporates a thin mesh netting in the sheet to enhance dimensional stability and prevent easy tearing. In clinical use a therapist will use scissors to cut the sheet into a desired shape. Klarity Bolus is tacky and self-adherent, so it can be layered to a desired thickness. The shaped piece will be placed on the patient's skin in a chosen location, where it will adhere enough to stay in place but can be easily removed. Klarity Bolus has less tackiness than other bolus materials, a manufacturing choice made in response to clinician complaints about the oily and overly tacky surface of other bolus materials. Sheets are semi-transparent, allowing a therapist to see the underlying treatment area. Klarity Bolus is for single patient use only, and can be discarded with normal hospital waste. For cleanliness reasons, gloves should be worn when working with bolus sheets. Klarity Bolus has been tested for tissue equivalency at 6 MV and 10 MV photon and at 6 MeV and 12MeV electron energy levels. Results compare favorably with the predicate device and other bolus materials. Further testing will be required to confirm performance with proton therapy systems.

To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting. In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate the most accurate treatment of tumors. Patients are those that have been diagnosed and are undergoing treatment for cancerous turnors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.

**Klarity Vacuum Cushions:** The Klarity Vacuum Cushions are similarly constructed with a polyurethane coated nylon material. The vacuum bags are filled with small polystyrene spheres. The Klarity Vacuum cushions are airtight and fitted with a self-closing valve for ease of use. When air is evacuated, the cushions contract to hold a rigid shape over the course of the radiation therapy treatment. **Klarity Mold Cushions:** The cushion has an inner component of small polystyrene spheres. These are surrounded by a 1/16" layer of polycaprolactone thermoplastic that softens and is moldable at 150° F. The thermoplastic layer has a nylon stockinette material surrounding it, for patient comfort.