Device Dossier

Treatment Delivery System - Accelerator system, linear

Device Dossier for Treatment Delivery System - Accelerator system, linear (Accelerator system, linear, Class IIb, sponsor Emergo). ARTG record, intended…

Intended purpose

The System is intended for the delivery of radiation therapy, stereotactic body radiotherapy or stereotactic radiosurgery (SRS) to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. The megavoltage x-ray radiation is delivered using rotational, non-rotational, intensity modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) treatment techniques and using image-guided (IGRT) or non-image-guided workflows in accordance with the physician approved plan.

TGA Public Summary