Device Dossier

Accelerator system, linear

Device Dossier for Accelerator system, linear (Accelerator system, linear, Class IIb, sponsor Elekta). ARTG record, intended purpose, GMDN category —…

Intended purpose

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

TGA Public Summary