Device Dossier
Elekta Medical Linear Accelerator - Accelerator system, linear
Device Dossier for Elekta Medical Linear Accelerator - Accelerator system, linear (Accelerator system, linear, Class IIb, sponsor Elekta). ARTG record,…
- GMDN category: Accelerator system, linear
Intended purpose
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.