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The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

This submission describes a modification to the currently marketed multi-leaf collimator (MLC) cleared as part of the MRIdian Linac system (K162393) intended to enhance beam resolution. The current MLC is comprised of 60 tungsten leaves in two opposing 30-leaf banks. The design modification discussed in this submission essentially divides the two existing leaf banks in half splitting them along the leaf motion direction and shifting the banks by one half of a leaf width. The "tonque and groove" is eliminated from the leaves and the shifted banks act effectively as better focused "tongue and groove" mechanism. As with the predicate, each MLC layer of the modified MLC is focused to a point beyond the source point of the Linac radiation to improve interleaf leakage performance. In this system, the focus point is 15 mm further away than the source point. The minimum projected leaf width then becomes one half the physical projected leaf width. The projected leaf width is 8.3 mm and the projected half leaf width is 4.15 mm. The modified MLC design has two layers of opposing tungsten leaves; the top and bottom layers have 34 and 35 leaves in each bank respectively for a total of 138 leaves. There have been no other changes to the cleared MRIdian Linac system (K162393).

The ViewRay (MRIdian) Linac System, with magnetic resonance imaqinq capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The MRIdian Linac system delivers ionizing radiation using a magnetic resonance imaging system (MRIS) unit for image quidance and a 6MV linear accelerator to deliver radiation therapy. The system is designed so that the imaging and radiotherapy fields of view coincide permitting imaging of the patient at the radiotherapy isocenter before and during treatment. The MRIdian Linac system is used with the ViewRay Treatment Planning and Delivery System (TPDS) (K102915). As with the predicate MRIdian System (K111862), the MRIdian Linac System consists of three primary subsystems: The Treatment Planning and Delivery System (TPDS), The Magnetic Resonance Imaging System (MRIS), and The Radiation Therapy Delivery System (RDS). These three subsystems are designed to operate concurrently for accurate targeted administration of radiation therapy.

The ViewRay System, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The ViewRay™ System for Radiation Therapy is a single medical device that combines a magnetic resonance imaging system for image guidance, with a cobalt-60 radiation delivery system. The system is designed so that the imaging and radiotherapy fields of view coincide, permitting imaging of the patient at the radiotherapy isocenter before and during treatment. These imaging and radiation delivery systems are designed to operate together as the ViewRay System, for accurate, targeted administration of radiation therapy. The ViewRay System is used with the ViewRay Treatment Planning and Delivery System (TPDS) (K102915, FDA clearance 1/12/11). The magnetic resonance imaging system (MRIS) of the ViewRay System can be used by the clinician to perform three (3) different functions before and during the treatment of a patient. A trained clinician may choose to perform all, some, or none of the functions. These 3 functions are: - Treatment planning the images from the ViewRay MRIS can be used to perform pre-treatment and on-table planning. - Patient positioning Fast pilot or planning volumetric images can be used to position the patient. - Treatment gating (soft tissue tracking)- If the prescribing clinician employs this feature during therapy, planar MR images (in a single plane or in 3 planes) are taken continuously during therapy delivery, to control the beam based on anatomy motion. The ViewRay radiation delivery system (RDS) consists of: - Radioactive cobalt-60 sources - Source shielding heads and movement mechanism - Gantry and base - Multi-leaf collimators - Radiation therapy control system - User console The sealed cobalt-60 sources are housed in source-shielding heads made of tungsten alloy and depleted uranium encased with stainless steel. The heads are mounted on a ring gantry located between the gap in the MRIS magnets. The sources can be positioned for therapy (BEAM ON), standby (BEAM HOLD) and shielding (BEAM OFF) by the source movement mechanism. The beams from the sources are shaped to conform to the target using double focused multi-leaf collimators. The radiation therapy interfaces with the radiation treatment planning, imaging, gating, and dose calculation functions by means of the radiation therapy control system (RTCS). This system is the central point of control and is designed to provide fail-safe operation of the ViewRay System. The RTCS includes the Radiation Therapy Controller (RTC) and the Auxiliary Controller (AUXC). The AUXC provides secondary monitoring of the ViewRay System safety functions in the event of an RTC failure. The ViewRay System records patient information, treatment plans, dose administered during each fraction, the accumulated dose, imaging data, and system performance during treatment.

Use of the ViewRay™ Treatment Planning and Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

The ViewRay™ Treatment Planning and Delivery System (TPDS) provides tools for planning and delivery of external gamma beam stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. It is a computer-based device used by trained medical professionals. The Treatment Planning software is only designed to be used on the ViewRay radiation therapy system. The ViewRay TPDS is capable of assisting clinicians in reviewing, prescribing, tracking, and correcting the course of patient treatment using tools for contouring, visualization, data storage, anatomical target monitoring and reoptimization.