Singapore - English - HSA (Health Sciences Authority)

elekta pte. ltd. - radiology / imaging - elekta medical linear accelerator emla is intended 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. elekta harmony is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation,and hypofractionation in all areas of the body where such treatment is indicated. elekta harmony pro is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, hypofractionation and stereotactic delivery (sbrt;sabr) 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 pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body

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

elekta pty ltd - 32568 - stereotactic surgery system, neurological - the device incorporates three components: inner guide tube for electrode, outer guide tube for dbs lead and a mandrin. during insertion of the device all components are combined. the elekta/ inomed microdrive is used to position the device. after insertion the mandrin is removed and the electrode is inserted through the inner guide tube. after a successful mer the electrode and inner guide tube are removed. the dbs lead is inserted with the outer guide tube. the guide tubes are intended to be used for guiding electrodes in combination with the elekta/ inomed microdrive during surgical interventions on the brain. the guide tubes are designed to stop in the specific distance to the target, to guide electrodes used for micro electrode recording (mer) and deep brain stimulation (dbs).

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

elekta pty ltd - 11467 - electroencephalograph - the elekta neuromag? triux/triux neo is intended for use as a magnetoencephalographic (meg) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. when interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.

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

elekta pty ltd - 38399 - radiation measurement equipment, quality assurance, accelerator system - this aktina mechanical front pointer is intended to be used as a tool to assist in the determination of the mechanical isocenter of the elekta linac gantry.

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

elekta pty ltd - 42263 - collimator, therapeutic x-ray, fixed aperture size - the interlocked circular small field collimators are intended for use with the elekta line of digital medical linear accelerators (linac) for the creation of small circular fields. these fields are used for patients who require external beam radiation therapy or stereotactic radiosurgery of the cranial or extra cranial regions for the treatment of tumors or lesions.

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

elekta pty ltd - 61131 - radiological general-body positioning device - the moldcare cushion is intended for stabilizing the position of a patient during diagnostic imaging and radiotherapy, etc.

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. elekta infinity is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – sbrt; stereotactic ablative radiotherapy – sabr) 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 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 - the elekta neuromag triux is intended for use as a magnetoencephalographic (meg) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. when interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.

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. elekta synergy is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, and hypofractionation 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 pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.

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

elekta pty ltd -