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

elekta pty ltd - 38409 - brachytherapy applicator, remote afterloading, cervical/endometrial - cervix and endometrial applicators are used for treatment of cancerous tumors with a remote brachytherapy afterloader.

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

elekta pty ltd - 38436 - brachytherapy applicator, remote afterloading, general-purpose - provide a channel into the body for temporary delivery of a brachytherapy radioactive source.

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

elekta pty ltd - 38407 - brachytherapy applicator, remote afterloading, vaginal - gynaecologial applicator set is designed for use in medical intracavitary brachytherapy for treatment of cancerous gynological tumors.

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

elekta pty ltd - 40895 - patient positioning device, diagnostic imaging/radiotherapy, moulding system, vacuum - the bodyfix? is intended for use by radiologists and surgeons for: patient positioning and immobilization, stereotactic diagnostic localization, stereotactic radiotherapy of extracranial targets

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

elekta pty ltd - 61128 - stereotactic radiosurgical/radiotherapy arch head frame - fraxion is intended to be used for immobilisation, positioning and re-positioning during stereotactic radiotherapy (srt) in all parts of the brain and head in a linear accelerator environment. furthermore, fraxion is used to immobilise and position the head during image acquisition to support treatment planning. under certain circumstances (eg when the patient will not tolerate an invasive frame) fraxion may also be used for stereotactic radiosurgery (srs) in a linear accelerator environment.

Singapore - English - HSA (Health Sciences Authority)

elekta pte. ltd. - radiology / imaging - 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 breast tumors, lung cancers and other thoracic tumors,liver tumors,pancreatic tumors.

Singapore - English - HSA (Health Sciences Authority)

elekta pte. ltd. - radiology / imaging - intended to be used for the radiation therapy of defined target volumes anywhere in the body, as determined by a licensed medical practitioner.

Singapore - English - HSA (Health Sciences Authority)

elekta pte. ltd. - radiology / imaging - 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 medical practitioner in the delivery of ebrt to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. versa hd is intended to be used for single or multiple fractions using standard fractionation, 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 and for the treatment of functional disorders, such as trigeminal neuralgia. the emla is indicated for the delivery of curative and palliative intent ebrt to adult and pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.

Singapore - English - HSA (Health Sciences Authority)

elekta pte. ltd. - radiology / imaging - is an add-on micromlc system. it is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the x-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. it is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissue.

Singapore - English - HSA (Health Sciences Authority)

elekta pte. ltd. - radiology / imaging - atlas-based autosegmentation is a standalone software application that produces estimates of anatomy boundary contours needed for the creation of a radiotherapy treatment plan.