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The kVue IGRT Treatment Table Top, inserts, and accessories are designed to position and support patients undergoing radiation therapy. The kVue Treatment Table Top is designed to replace an original equipment manufacturer's stock table top. The Qfix kVue Patient Positioning Table Top and inserts are made using sliding beams and advanced fiber composites that contain no metal parts in the treatment area, thus allowing the devices to be used in various diagnostic and treatment modalities without fear of interference caused by metal parts. In particular these devices are designed for optimal performance when used with on board imaging and cone beam CT while simultaneously reducing beam attenuation for treatments that pass through the couch. The kVue inserts include the Cantilever Board insert, the Quest Breast Board insert, the prone breast board insert, the Ofix Pelvis/Belly Board insert, the Box Grid insert, the Solid Panel insert, the Center Spine insert, the DoseMax insert, and the removable tip extension. kVue accessories include the device adapter bar, the VacuFix Bags, the removable clamp rail, and the removable tip extension hardware.

The kVue IGRT Treatment Table Top, inserts, and accessories are designed to position and support patients undergoing radiation therapy. The kVue Treatment Table Top is designed to replace an original equipment manufacturer's stock table top. The Qfix kVue Patient Positioning Table Top and inserts are made using sliding beams and advanced fiber composites that contain no metal parts in the treatment area, thus allowing the devices to be used in various diagnostic and treatment modalities without fear of interference caused by metal parts. In particular these devices are designed for optimal performance when used with on board imaging and cone beam CT while simultaneously reducing beam attenuation for treatments that pass through the couch. The kVue inserts include the Cantilever Board insert, the Quest Breast Board insert, the prone breast board insert, the Ofix Pelvis/Belly Board insert, the Box Grid insert, the Solid Panel insert, the Center Spine insert, the DoseMax insert, and the removable tip extension. kVue accessories include the device adapter bar, the VacuFix Bags, the removable clamp rail, and the removable tip extension hardware.

This document is a 510(k) Premarket Notification letter from the FDA regarding the "kVue IGRT Treatment Table Top". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter is a regulatory approval document stating that the device is substantially equivalent to legally marketed predicate devices.

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