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The unit is intended to be used in: - delivering the intended dose at a specified position; . - delivering the radiation in accordance with the selected relationship of the . radiation to the patient (fixed or moving beam therapy, beam modifying device, etc.); - . delivering the radiation without causing unnecessary risk to the patient, the operator, other persons, or the immediate environment.

The Theratron Elite consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beam-stopper style counterweight. The design of this device is similar to predicate devices Theratron 780E and 1000E. The key difference is that the 'push-button' style control console on the predicate devices has been replaced with a modern PC based remote control console with graphic user interface and 'Record and Verify' communication capability.

THERAPLAN Plus Version 1.2 is intended to be used as a modelling system to assist health care professionals determine a course of Radiation Therapy to be delivered to a patient with cancer. It is designed to be used directly by a health care professional capable of assessing the suitability of the output for treatment planning purposes, or to have its output reviewed by someone with these qualifications prior to use.

THERAPLAN Plus Version 1.2 consists principally of application software running under a Windows operating system on a Pentium personal computer. Several THERAPLAN Plus Version 1.2 systems can be networked together for common access to pertinent data. The principal components of the THERAPLAN Plus Version 1.2 are listed below. Hardware platform and Operating System: Pentium PC, Windows NT Peripherals and accessories: Electromagnetic digitizer for manually entering patient anatomy, film scanner for entering anatomy from films, 9 track magnetic tape unit for entering CT and MR images of patient anatomy, laser text printer, 300 dpi, 4 pages per minute minimum, colour printer, 300 dpi. Main software features: Unit Modelling of electron and photon beams from accelerators or Cobalt therapy units. Includes entry of wedges, blocks, and multileaf collimators. Source Modelling of point sources, line sources and wires. The operator selects parameters for the sources which are required for treatment planning, such as size, isotope, wall thickness, and half-life. Patient Data Acquisition by means of CT or MR images, a film scanner, or manually entered contours. CT or MR data may be acquired directly for units which support the DICOM 3 image format and communication standard, or by means of a software interface supplied by Theratronics for other units. Anatomy Modelling to prepare the patient data for treatment planning. The portions of the anatomy which are of interest are selected, and contouring is performed of the anatomy exterior, the treatment target volume, and interior organs as needed for treatment planning. Brachytherapy Planning may be performed using sources established during Source Modelling. The location of multiple sources may be specified and sample dose calculations performed. The location of sources may be adjusted for optimization. Timedomain calculations may also be performed based on the pattern of sources and their halflives. External Beam Planning may be performed using Unit Modelling data and Anatomy Modelling data. Electron and/or photon beams of different treatment units may be applied, and dose calculations performed. The location of the beams may then be adjusted for optimization. Arc therapy treatments can also be modeled. The THERAPLAN Plus Version 1.2 also includes facilities for the operator to print the treatment plan information for review and to assist with the patient's treatment, and a compensator can be designed to help optimize the radiation pattern of an applied beam.

A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the A Cobalt Teletherapy and is a do not of health care professionals in a radiation therapy clinic. The unit is intended to be used in: - delivering the intended dose at a specified position; . - delivering the radiation in accordance with the selected relationship of the radiation to the . patient (fixed or moving beam therapy, beam modifying device, etc.); - . delivering the radiation without causing unnecessary risk to the patient, the operator, other persons, or the immediate environment.

The Theratron 780E consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is similar as the predicate device Theratron 780C with improved safety features and radiation shielding in the collimator area of the unit head assembly.

A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.

The Theratron 1000E consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is similar as the predicate device Theratron 1000 with improved safety features and radiation shielding in the collimator area of the unit head assembly.