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This is to certify that the BodyLoc™™ Whole Body Stereotactic Localizer System For Radiotherapy, as submitted under the above referenced 510(k) number, is indicated for use as a precision patient immobilization and positioning system for the purpose of performing diagnostic localization and fractionated stereotactic radiotherapy/ radiosurgery treatment. It is substantially equivalent to similar devices which are used to position the body during stereotactic radiotherapy of various body lesions. The decision and conditions under which the system is to be used is made by the patient's managing physician(s).

The BodyLoc" is a body stereotactic localizer system which utilizes a coordinate reference system that can be used to reproducibly localize targets during diagnostic and treatment procedures. Stereotactic localization fiducials are positioned in the sides and base of the BodyLoc™ and the localization system is continuous from the head to mid-thigh regions. The BodyLoc" is supplied with a software program for calculation of BodyLoc" stereotactic coordinates from scanner images. Software is functional on IBM or IBM-compatible PC computers with Microsoft® Windows 95. Targets within the system can be aligned by use of the coordinate indicators on the sides of the frame and the moveable arc localizer. Immobilization is achieved by the use of a vacuum mold system or polyurethane foam mold for posterior (the part of the body nearest the frame base) areas and a thermoplastic body mold to cover large body surfaces in the ventral or anterior plane. The BodyLoc™ has quality assurance markers in its base which are used to aid in system set-up and in verifying the accuracy of the coordinate alignment and target calculations.

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MIDCO has recently developed a quality Couchmount System (Patient Head Support System) for use in radiosurgery. This couchmount system complements the cass collimator set and enables MIDCO to provide its customers with a full set of instrumentation necessary for radiosurgery. The design of this couchmount is such that it will fit most linear accelerators with only slight modifications to the couchmount adapter assembly. The cass Couchmount System has six axes of adjustment which allows for easy setup with the Linac couch/gantry system. An additional feature of the system is a unique laser measurement apparatus for precisely measuring an isocenter of a target volume for Linac-based radiosurgery/stereotactic radiotherapy. These two features also allow for the correction of alignment errors during treatment planning setup, such as errors inherent in the use of room lasers and errors due to couch shifts during patient positioning. It will also give an index of gantry sag or misalignment. Most commercially available stereotactic headrings can be mounted to the cass Couchmount System by the use of a stereotactic frame holder made specifically for the headring. Although most headrings are similar, each has a slightly different adapter plate which rigidly holds the headring. The stereotactic localization features of most frames are similar, differing mainly in the organization of the frame's coordinate system and its mechanical dimensions.