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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.

The MRIdian Linac system is an image-quided radiation therapy (IGRT) system that uses a 6 MV linear accelerator radiotherapy system to deliver ionizing radiation while using a magnetic resonance imaging system for image guidance in real time. The MRIdian consists of the Treatment Planning and Delivery System (TPDS), 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 MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation treatment is indicated.

The MRIdian Linac system (K162393; K170751) delivers ionizing radiation using a magnetic resonance imaging system (MRIS) unit for image guidance. This submission describes an optional change only to the treatment planning and delivery imaging workflows of the predicate MRIdian Linac system. ViewRay developed the following additional imaging modalities for use during MRIdian Linac system treatment planning and delivery workflows: 1. Introduction of a Treatment Delivery Computer Unit (TDCU) to increase treatment imaging reconstruction and display speed in excess of eight frames per second along with improved cine image resolution used for target tracking. 2. The predicate MRIdian Linac system supports the import of MR images obtained from a separate imaging system for use in treatment planning. In addition to importing additional MR images, the proposed MRIdian Linac system is also able to generate the following additional MR sequences for use during planning, positioning, and treatment delivery workflows: a. Turbo Spin Echo (TSE) pulse sequence family including Half Fourier Acquisition Single Shot Turbo Spin Echo (HASTE) and Diffusion Prepared Turbo Spin Echo (DP-TSE) which enables the following contrast protocols: i. T1-weighted (spin-lattice; magnetization in the same direction as the static magnetic field); ii. T2-weighted (spin-spin; magnetization transverse to the static magnetic field); and iii. Diffusion-Weighted Imaging (DWI) with ability to generate Apparent Diffusion Coefficient (ADC) maps to overlay and register to other images. b. True Fast Imaging (TRUFI) pulse sequence with radial sampling enabling higher speed imaging during treatment delivery. The currently marketed MRIdian Linac system integrates radiation therapy with simultaneous magnetic resonance imaging of soft tissues to provide optimal alignment, adaptation, and tracking. These proposed changes to the existing system described in this section aim to improve MR imaging speed and quality and provide additional image contrast modalities.