Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 42303 - x-ray film ruler - the aktina port film graticule is intended to be used for radiation therapy to project a scale of defined increments on port film images which can aid in treatment setup and verification.

Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 38302 - radionuclide source, therapeutic, brachytherapy, remote afterloading - the devices are radioactive isotopes used as a source of radiation in a high or low dose rate remote afterloading brachytherapy system designed to deliver curative or palliative radiotherapy treatments.

Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 47783 - general-purpose surgical drape, single-use, sterile - surgical or patient drapes consist of natural of synthetic materials and are intended to be used as a protective patient covering during surgical procedures. the primary purpose of the drape is to isolate a site of surgicalincision from microbial or other contaimination.

Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd -

Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 40887 - radiation therapy treatment planning system, application program software - radiotherapy software quality assurance tool designed to compare the dose reconstructed from portal images to the dose planned by a treatment planning system for photon beams.

Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 40887 - radiation therapy treatment planning system, application program software - epibeam is a standalone software tool independent of the linear accelerator, the tps and the record-and-verify system. it is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery. it is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification. the software is to be used for the purposes of detecting errors in the delivery of radiation therapy prior to treatment, like corruption of the transferred plan data to the treatment unit, inappropriate multileaf collimator sequence or beam output malfunctioning. the software acquires data from the electronic portal imaging device (epid) during a blank fraction dedicated to the pretreatment verification without the presence of the patient and subsequently processes it. the processed data is compared with data calculated by the epibeam system. the comparison is derived on one hand, from the application of dose conversion to the epid data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. a gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user.

Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 38399 - radiation measurement equipment, quality assurance, accelerator system - the iqm integral quality monitor is a large-area ionization chamber intended to be used for quality assurance verification measurements and documentation of the treatment delivery accuracy (beam shape, position and dose) from medical linear accelerators used for intensity modulated radiation therapy. the data acquired by iqm is used to compare and verify a treatment dose (delivered dose) to the expected dose and to compile treatment delivery radiation beam data and consistency data over time as part of a quality assurance program.

Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 57967 - clinical data collection/management information application software - kaiku health is intended for use in cancer care and follow-up for non-urgent communication between an adult patient and a medical professional and for collecting patient-reported data, displaying and analysing clinical and patient-reported data, and instructing the patient. the data processed by kaiku health are intended to be used in supporting treatment decisions and in supporting diagnoses.

Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 40887 - radiation therapy treatment planning system, application program software - mu2net is indicated for use as a quality assurance software to verify conventional, imrt and vmat treatment plans provided by radiotherapy treatment planning systems and transferred as dicom rt data sets. it is also indicated for use as a quality assurance software to manage in vivo measurements performed during the treatment patient fractions. mu2net is dedicated to be used by high qualified professionals in medical oncology and/or medical physics such as radiation-oncologists, medical physicists and technicians performing treatment planning.

Australia - English - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 65365 - full-body ct/general-purpose fluoroscopic x-ray system - the irm is a mobile x-ray system to be used for 2d planar and fluoroscopic and 3d imaging for adult and pediatric patients. it is intended to be used where 2d and 3d information of anatomic structures such as bony anatomy and soft tissue and objects with high x-ray attenuation such as (metallic) implants is required. the irm provides an interface that can be used by system integrators for the integration of the irm with image guidance systems such as surgical navigation systems