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The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. Device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The device is not intended for use with patients under 12 years of age.

The Breastboard and Overhead Arm Positioner are used to position the patient during external beam radiation therapy. The Breastboard is comprised of a Base, Back Support, and Bottom Stop. The Base serves as the foundation of the assembly and provides a mounting surface for the Back Support, Angle Supports, and the Bottom Stop. The inferior end of the Back Support is mounted to the Base while the superior end of the Back Support is raised/lowered as needed for patient setup using Low Angle Supports. The Bottom Stop is located near the inferior end of the Base and prevents the patient from sliding down the Board. The Low Angle Support is used to position the Back Support at 5°, 7.5°, 10°, 12.5°, and 15° angles. Features on the High Angle Support receive the cutouts on the Low Angle Support and hold the angular position of the Support. The High Angle Support is used to position the Back Support at 17.5°, 20°, 22.5°, and 25° angles. Features on the Base receive the cutouts on the High Angle Support and hold the angular position of the Support. A Lock provides a method of locking the Back Support to the Base at 0° to facilitate easier handling and storage of the Breastboard. The Overhead Arm Positioner provides support for the patient's arms above the head and is attached to the Back Support via a locking assembly. The Overhead Arm Positioner adjusts longitudinally on the Back Support to accommodate a variety of patient sizes. A Hand Grip is mounted on the Overhead Arm Positioner and the location of the Hand Grip is adjustable longitudinally. A Head Support rests on a recessed area of the Overhead Arm Positioner and provides a cushion for positioning of the head of the patient. The Head Support can also be mounted directly on the Breastboard. A Thermoplastic Frame may also be mounted to the Overhead Arm Positioner to enable attachment of a thermoplastic mask for additional patient support. The Breastboard and Overhead Arm Positioner can also be used for supporting and elevating patients undergoing treatment who cannot lay down flat on the table due to their habitus. The Breastboard and Overhead Arm Positioner are reusable devices that are provided nonsterile.

The device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and proton treatments, and simulation including CT and MR image acquisition.

The Respiratory Plate with Cushion and Respiratory Belt are components of a modularbased patient positioning system that indexes directly to a treatment or simulation couch. The Respiratory Plate is comprised of a compression plate, mount, index screw, and screw wheel. Rotation of the screw wheel lowers and raises the compression plate. The mount is attached to the positioning system bridge using pins, and the bridge is indexed to the system platform using a clamping mechanism. A Cushion is mounted on the compression plate via pocket features on the Cushion. The Cushion is comprised of three compartments of beads plus an air chamber. The Cushion is inflated with air to the desired pressure using a hand-held pump accessory with reference pressure qauge. The Respiratory Belt is comprised of a central air chamber with indexing scale. Velcro straps, hand pump, pressure gauge, and clamps. The Velcro straps allow the Belt to be tightened or loosened around the patient. The Belt is inflated using a hand pump and the pressure is monitored with a reference pressure gauge. Clamps are used to attach the Velcro straps to the positioning system platform. The Respiratory Plate with Cushion and Respiratory Belt are reusable devices that are provided non-sterile and are manufactured of non-magnetic materials with the exception of the pressure gauge. The devices are used in a healthcare facility/hospital.

The device is intended to be used for immobilization, positioning and re-positioning during Stereotactic Radiotherapy (SRT) and Stereotactic Radiosurgery (SRS) in all parts of the brain, head, and neck during external beam radiation therapy. The device is also used to immobilize and position the head during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems.

The Head Immobilization System is intended for head and neck immobilization. The device is used as an aid in positioning and re-positioning of the patient during diagnostic and therapeutic treatments including radiation therapy. The fundamental component of the system is the trUpoint ARCH™ comprised of an arch, frame arm, bite assembly arm, and nasion assembly arm. A nasion cushion and bite cup also comprise the system. A storage plate is used to store the trUpoint ARCH™ and a Base Lock Replacement Kit is available to replace the base lock in the trUpoint ARCH™. Accessories to the proposed device that are manufactured by CIVCO Medical Solutions include the individual head support, thermoplastic mask, and baseplate. Accessories to the proposed device that not manufactured by CIVCO Medical Solutions include a bite tray, impression putty, and putty dispenser. The proposed devices are sold non-sterile. The nasion cushion and bite cup are single patient use devices whereas the trUpoint ARCH™ may be reused for multiple patients. The proposed devices are non-implanted devices that are large in size and manufactured of non-magnetic and plastic materials.

CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.

CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s for use in radiological and other medical procedures. This 510(k) is to have these Class II products cleared for use in an MR environment. Various sizes and shapes of patient positioning devices are offered in order to install on a specific system which the device is used on and/or the body region to be positioned. Devices are sold non-sterile and may be re-used for multiple patient or single patient use if set-up for a single patient.

Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.

The CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s. This 510(k) is to have these identical Class II products cleared for use in an MRI environment.

The intended use of the MED-TEC, INC. Carbon Fiber Breast Board is to support and aid in positioning a patient during radiologic and other medical procedures.

Carbon Fiber Breast Board

The intended use of this device is to sheild healthy tissue from radiation. The MED-TEC, INC. MT-MX3 thermoplastic shield MATRIX operates in the same manner as other personnel protective shields. or The intended use of the MED-TEC, INC. MT-MX3 MATRIX thermoplastic shield is to shield healthy tissue from radiation.

MED-TEC, INC. has a Personnel Protective Shield System to be manufactured by MED-TEC, INC.

The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures.

MED-TEC, INC. has a Table, Radiographic, Stationary Top System to be manufactured by MED-TEC, INC. The MED-TEC, INC. Carbon Fiber Conformal Couch Top operates in the same manner as an ordinary couch.