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The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy stereotactic body radiotherapy (SBRT), or stereotactic radiosurgery (SRS) to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. The megavoltage x-ray radiation is delivered using rotational, intensitymodulated (IMRT), or non-modulated (non-INRT/three-dimensional conformal) treatment techniques and using imageguided (IGRT) or non-image-guided workflows in accordance with the physician-approved plan. The Radixact Treatment Delivery System integrates Surface Guided Radiation Therapy (SGRT) for patient position and motion monitoring, and breath-hold gating.

The predicate and modified Radixact Treatment Delivery Systems are radiation therapy delivery systems, that provide megavoltage CT imaging capabilities coupled with x-ray radiation delivery. The system achieves delivery using rotational, intensity modulated (IMRT), or non-modulated (non-IMRT/three-dimensional conformal) radiation therapy treatment techniques utilizing image-guided (IGRT) or non-image-guided workflows, to tumors or other targeted tissues anywhere in the body, in accordance with the physician-approved plan. The additional feature update: VitalHold incorporates an external optical monitoring system (EMS), which is integrated with the Radixact system to enable Surface Guided Radiotherapy (SGRT) for patient setup, patient position and motion monitoring, and breath-hold gating. Neither the predicate Radixact Treatment Delivery System nor the modified Radixact Treatment Delivery System diagnose disease or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use.

The Accuray Precision® Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

The Accuray Precision® Treatment Planning System is a radiation therapy planning system used for the creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. The radiation treatment plan is developed by using diagnostic CT (primary image series) and/or secondary images (MR and PET) of the patient previously acquired prior to treatment and saved into the central database server (iDMS Data Management System). The images are imported from the database server into the Accuray Precision® Treatment Planning System to register/ fuse for dose calculation, and to accurately define/contour regions of interest (target) and the surrounding critical anatomical structures to avoid. The user (dosimetrist/ medical physician) then specifies the treatment delivery machine (CyberKnife or TomoTherapy systems, Radixact systems), treatment delivery mode (e.g., 3DCRT, IMRT) and the patient alignment at the treatment machine. This is followed by specifying the radiation dose criteria for the identified regions of interest, as well as the number of fractions over which this dose is to be administered. After the relevant data has been entered, the user initiates the treatment plan calculation or optimization process. When the treatment plan has been calculated, the user may refine the plan with adjustments to the regions of interest, avoidance structures, and dose criteria and re-optimize the plan. Once an optimized treatment plan is produced that meets the requirements of the intended therapy, the prescribing physician approves the plan for delivery and the plan is saved on the database server as a treatment delivery plan. The plan reports are also printed for the patient record.

The kVCT Imaging Feature is an option within the indications for use of the Radixact Treatment Delivery System. The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

The kVCT Imaging Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The primary functions of the kVCT Imaging Feature are: 1) acquisition of kV x-ray images according to input protocols in concert with other subsystems, 2) correcting 2D images and 3) returning reconstructed 3D images. The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.

The Motion Tracking and Compensation Feature is an option within the indications for use of the Radixact Treatment Delivery System. The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

The Motion Tracking and Compensation Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The Motion Tracking and Compensation Feature measures tumor location and motion using images provided by a kV imaging subsystem and predicts tumor location based upon a respiration amplitude measurement device. The Radixact Treatment Delivery System then compensates for tumor motion by making real-time adjustments. The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.

The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

The TomoTherapy Treatment Delivery System with iDMS is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues. The TomoTherapy Treatment Delivery System with iDMS is a modified version of the predicate TomoTherapy Treatment System (last cleared on K121934). The TomoTherapy Treatment Delivery System with iDMS is the same as the predicate device minus the Data Management System and Treatment Planning Station, but substituting the Treatment Delivery Console (TDC) from the Radixact Treatment Delivery System (last cleared on K161146) in place of the predicate Operator Station. The TomoTherapy Treatment Delivery System with iDMS is designed to deliver radiation therapy treatment plans generated on planning systems such as the Accuray Precision™ Treatment Planning System (last cleared on K171086) and stored on data management systems such as the Accuray iDMS™ Integrated Data Management System (last cleared on K161144).

The Accuray Precision™ Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery. The Accuray Precision™ Treatment Planning System is intended to be used by physicians, medical physicists, and dosimetrists to generate radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment plans. Plans may be created with the Accuray Precision™ treatment planning system for delivery using Intensity Modulated Radiation Therapy (IMRT) or 3-D Conformal Radiation Therapy (3DCRT) techniques. The users will be able to create a plan that satisfies established clinical objectives. For stereotactic radiosurgery, the plan will generally involve delivering a tumoricidal dose to target tissue, while minimizing dose to other tissues. For radiation therapy and stereotactic radiotherapy, the plan will generally involve delivering a damaging dose to diseased tissue at a level that allows healthy tissue in the target volume to recover, while also minimizing dose to tissue outside the target volume. The treatment plan with dose distributions and complete delivered dose value along with the input data will be available through a user display or printed report for user review and evaluation against the treatment prescription and established physics models. The treatment plan will then be saved by the user, approved by the qualified medical practitioner, and subsequently delivered by the treatment delivery system.

The Accuray Precision™ Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. The radiation treatment plan is developed by using diagnostic CT (primary image series) and/or secondary images (MR and PET) of the patient previously acquired prior to treatment and saved into the central database server (iDMS™) Data Management System). The images are imported from the database server into the Accuray Precision™ System and registered/ fused for dose calculation and to accurately define/contour regions of interest (target) and the surrounding critical anatomical structures to avoid. The user (dosimetrist/ medical physician) then specifies the treatment delivery machine (CyberKnife® or TomoTherapy® systems), treatment delivery mode (e.g. 3DCRT, IMRT) and the patient alignment at the treatment machine. This is followed by specifying the radiation dose criteria for the identified regions of interest, as well as the number of fractions over which this dose is to be administered. After the relevant data has been entered, the user initiates the treatment plan calculation or optimization process. When the treatment plan has been calculated, the user may refine the plan with adjustments to the regions of interest, avoidance structures, and dose criteria and re-optimize the plan. Once an optimized treatment plan is produced that meets the requirements of the intended therapy, the prescribing physician approves the plan for delivery and the plan is saved on the database server as a treatment delivery plan. The plan reports are also printed for the patient record.

The Precision™ treatment planning system is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

The Precision™ Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. It includes the planning system features of both the currently marketed predicate devices: CyberKnife MultiPlan Treatment Planning System (K150873) and the TomoTherapy Planning Station (K121934). Hence, the Precision Treatment Planning System is intended for treatment planning for multiple platforms: - · Accuray's robotic radiosurgery systems, including but not limited to the CyberKnife® Treatment Delivery System (last cleared K150873). - · Accuray's ring gantry systems, including but not limited to the Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System (last cleared K121934).

The iDMST™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.

The subject device, iDMS™ Data Management System, is essentially the CyberKnife® Data Management System (CDMS) cleared in the predicate device, the CyberKnife® Robotic Radiosurgery System. This submission simply establishes the iDMS™ System as a stand-alone data management system and reflects its integration with Accuray's robotic radiosurgery and ring gantry systems, including but not limited to the CyberKnife® System and Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System. As such, modifications are limited to those required to integrate the iDMS™ System with the Radixact™ System which is a next generation TomoTherapy® Treatment System. The iDMS™ System is a data management system that provides storage, applications and interfaces to access, add, modify, export, delete, and validate patient, user and system data for Accuray's radiotherapy, stereotactic radiotherapy, and stereotactic radiosurgery delivery systems, including but not limited to the CyberKnife® System and Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System, as well as treatment planning systems, including the Precision™ Treatment Planning System. The IDMS™ System can store and retrieve treatment plans and delivery data for multiple systems.

The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues. The Radixact Treatment Delivery System is an updated design of the radiation delivery elements of the predicate TomoTherapy Treatment System (last cleared on K121934). The Radixact Treatment Delivery System delivers radiation therapy treatment plans generated on planning systems such as Accuray's Precision™ Treatment Planning System and stored on Accuray's iDMS™ Integrated Data Management System devices. The planning and data management devices are not addressed in this 510(k). The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. As with the TomoTherapy Treatment System, the Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, it is not intended for diagnostic use.

The Onrad™ Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

The Onrad™ Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system. The Onrad™ Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.