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MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (Ver. 3.5)") is an Image-Guided Radiation Therapy device generating 6MV high energy X-ray for precision radiation therapy of tumors and conditions, where radiation treatment is indicated. It includes a linear accelerator, multi-leaf collimator, electric portal imaging device and couch. It also includes O-ring-type gantry platform, X-ray-head-mounted gimbals, Built-in Imaging System, and function to continuously align treatment beam with moving target for precise radiotherapy of moving targets, as notable characteristics. The MHI-TM2000 (Ver. 3.5) has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K122450 (hereinafter called "MHI-TM2000 (K122450)''). Modification was made for introducing a method of radiation therapy called "Dynamic WaveArc" ("DWA") that delivers radiation while rotating both O-ring-shaped gantry (Gantry rotation) and rotational floor of the gantry that moves entire gantry (Ring rotation), or rotating the Ring rotation only. Radiation type, energy, and the method of generating radiation are identical between MHI-TM2000 (Ver. 3.5) and MHI-TM2000 (K122450)

MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (VER. 3.0)") has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K072047 (hereinafter called "MHI-TM2000 (K072047)"). MHI-TM2000 (VER. 3.0) introduces a new interface functionality for remotely controlling gimbaled motion (pan and tilt motion) of X-ray tube and MLC, based on position data received from radiation therapy positioning system "ExacTrac Vero", which is compatible 3rd party device manufactured by Brainlab AG. This functionality enables continuous alignment of treatment beam with moving target resulting in precise radiation treatment of moving targets. The gimbal mechanism (pan and tilt) is one of the unique characteristics of MHI-TM2000 (K072047), which is called "X-ray-head-mounted gimbals". The "X-ray-head-mounted gimbals" have been used to compensate for the residual mechanical deformation, mainly caused by gravity, but the MHI-TM2000 (VER. 3.0) utilizes this mechanism further for moving treatment-X-ray beam axis for continuously aligning it with moving target. A new interface (communication board) for receiving position data is equipped to System Controller Panel of MHI-TM2000 (VER. 3.0). The method of generating radiation and irradiation are the same as MHI-TM2000 Linear Accelerator System (K072047).