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The Explorer 4D™ Treatment Planning System software is intended for use in preparing treatment plans for patients who have intracranial diseases where neurological radio surgery has been prescribed. The software is used to electronically import CT and MR images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

The Explorer 4D™ Treatment Planning System (TPS) provides individual treatment plans for patients undergoing gamma radiation therapy treatment. The TPS provides for the import of patient images and selecting a series of relevant patient images to create a treatment plan. Precise calculation of the dose delivery parameters is supported by the registration of fiducial markers as a reference point between patient images. These images are then annotated with the region of interest (ROI) to be exposed to radiation. Several tools are provided to adjust the ROI based on the desired treatment area, within these regions "shots" (radiation sources) and associated treatment dose levels are defined as they related to a specified collimator size. When the plan definition is completed the operator can save or export the treatment plan.

The Explorer 4DTM Treatment Planning System software is intended for use in preparing treatment plans for patients who have intracranial diseases where neurological radio surgery has been prescribed. The software is used to electronically import CT images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

The Explorer 4D™ Treatment Planning System (TPS) provides individual treatment plans for patients undergoing gamma radiation therapy treatment. The TPS provides for the import of patient images and selecting a series of relevant patient images to create a treatment plan. Precise calculation of the dose delivery parameters is supported by the registration of fiducial markers as a reference point between patient images. These images are then annotated with the region of interest (ROI) to be exposed to radiation. Several tools are provided to adjust the ROI based on the desired treatment area, within these regions "shots" (radiation sources) and associated treatment dose levels are defined as they related to a specified collimator size.

The Rotating Gamma System, GammaART 6000 is intended to be used by licensed Medical Professionals for radiation treatment of selected intracranial abnormalities. previously cleared for the OUR Rotating Gamma System and the Leksell Gamma Knife. The Rotating Gamma System, GammaART 6000 is a tele-therapy radiation treatment device intended to be used for stereotactic irradiation of intracranial structures. The device is to be used by licensed medical professionals, having been trained in the use and safety precautions of this device.

This 510(k) Special Submission if for a modification to cleared K970647 Rotating Gamma System that has received a motion controller upgrade. The ACS SB214ND 4axis motion controller (P/N: D-000024) has been replaced with the new Galil DMC-2000 5-axis motion controller (P/N: C-000141). The Rotating Gamma System, GammaART 6000 is a tele-therapy device which contains 30 Cobalt-60 sources distributed on a hemispheric shielded source carrier. Inside the source unit is the "built in" secondary collimator which has four sides of collimators and one block position. When not treating, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter. Treatment starts with aligning the sources to the prescribed collimator size, then both the source unit and the secondary collimator rotate as one unit. By rotating the Cobalt-60 sources, 30 nonoverlapping full 360 degree arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra.