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XPlan 2.2 software is a stereotactic LINAC-based ration treatment planning system. XPlan 2.2 with the Body System localizes lesions to be treated using CT scans, MR scans, and digitized anglographic film. XPlan 2.2 with the Body System provides stereotactic planning system for treatment of tumors. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.

The above system consists of stereotactic treatment planning software and hardware to immobilize and localize the patient.

No information about acceptance criteria or a study proving the device meets said criteria can be found in the provided text. The document is a 510(k) summary for a medical device (Radionics XPlan 2.2 with the Body System) and an FDA clearance letter. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's intended use and regulatory classification. There is no mention of specific performance metrics, clinical studies, or data used to validate the device's accuracy or efficacy.

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