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

elekta pty ltd - 35159 - accelerator system, linear - the elekta medical linear accelerator (emla) is intended to be used for external beam radiation therapy (ebrt) treatments as determined by a licensed medical practitioner. ? it is intended to assist a licensed practitioner in the delivery of ebrt to defined target volumes, whilst sparing surrounding normal tissue and critical organs from excess radiation. it is intended to be used for single or multiple fractions of standard dose fractions, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy ? sbrt; stereotactic ablative radiotherapy- sabr; stereotactic radio surgery ? srs); in all areas of the body where such treatment is indicated. ? the emla is indicated for the delivery of curative and palliative intent ebrt to adult and paediatric patients with primary benign and malignant tumors, metastases (or secondaries), and functional indications.

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

elekta pty ltd - 35159 - accelerator system, linear - elekta unity using magnetic resonance imaging, is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a define treatment plan. elekta unity is intended for use with compatible treatment planning and oncology information systems. the elekta unity 1.5t mri scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during and after the radiotherapy treatment. when interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology

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

elekta pty ltd - 45065 - patient monitoring system, respiratory, radiation procedure - the active breathing coordinator is indicated for use when there is a need to reduce the anatomical movement in the thorax and abdomen caused by breathing and cardiac motion. it is intended for breath-hold (bh) during simulation and delivery of external beam radiation therapy (ebrt) using photons, in single or multiple fractions, administered via static and/or dynamic delivery processes, in any and all areas of the body where such treatment is indicated. it also provides electrical prompts and status information for the elekta limited response? gating interface when automated gating of the linac is used.the active breathing coordinator is specifically indicated for:a. breast tumors, including total and partial breast irradiation techniques, where immobilized anatomy provided by deep inspiration breath-hold (dibh) allows critical organ sparing, such as decreasing radiation dose to heart, lung and other surrounding normal tissue.b. lung cancers and other thoracic tumors (such as esophagus, lymphoma, and metasta

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

elekta pty ltd - 40897 - patient positioning device, diagnostic imaging/radiotherapy, indexed immobilization - the elekta unity ct overlay is intended to support the patient during ct imaging procedures for radiation therapy applications. it is designed to be attached on the flat top of the original ct cradle

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

elekta pty ltd - 45446 - patient positioning system, ultrasound - clarity? is indicated for use in external beam radiation therapy. it provides 3d ultrasound and hybrid imaging of soft tissue anatomy to aid in radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment (image guided radiation therapy). when configured with an autoscan probe kit for transperineal ultrasound (tpus) imaging, clarity? may be used to continuously track and monitor the motion of the prostate and to accurately and precisely guide patient positioning during the delivery of treatment (intrafractional position tracking and monitoring). when configured with a gating option, clarity? may also interface with radiation delivery systems equipped with a compatible external gating control device. with this option, while in tracking and monitoring mode, clarity? can signal the radiation delivery system to automatically impose a beam-hold when the position of the tracked anatomy has exceeded pre-defined monitoring (tracking) limits, and signal again to relea

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

elekta pty ltd - 40887 - radiation therapy treatment planning system, application program software - the monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. the system calculates dose for photon, proton and electron treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. the monaco product line is intended for use in radiation treatment planning. it uses generally accepted methods for: contouring; image manipulation; simulation; image fusion; plan optimization; qa and plan review.

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

elekta pty ltd - 40885 - radionuclide system, therapeutic, stereotactic radiosurgery, application program software - leksell gammaplan is a computer-based system designed for leksell gammaknife treatment planning

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

elekta pty ltd - 38297 - radionuclide system, therapeutic, teletherapy - leksell gamma knife? perfexion is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors, arteriovenous malformations, trigeminal neuralgia, meningiomas; and vestibular schwannomas.

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

elekta pty ltd - 38563 - biopsy kit, brain - these needles are an alternative to reusable biopsy needles addressing concerns regarding cross?contamination. the kit includes a disposable sidecutting biopsy needle with an 8.0 mm needle window and an aspiration tube. the kit also includes a disposable stop and guide to further reduce the risk of crosscontamination. the disposable biopsy needle kit is designed for performing brain biopsies using leksell stereotactic system?. this device should only be used by a physician/surgeon trained in the use of leksell stereotactic system? and brain biopsy needle devices and procedures.

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

elekta pty ltd - 38297 - radionuclide system, therapeutic, teletherapy - leksell gamma knife? icon? is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters, e.g. metastatic tumors, arteriovenous malformations, trigeminal neuralgia, medically refrectory essential tremor, meningiomas, vestibular schwannomas, post-surgical pituitary adenomas and recurrent glioblastomas.