Device Dossier
Accelerator system, linear
Device Dossier for Accelerator system, linear (Accelerator system, linear, Class IIb, sponsor Emergo). ARTG record, intended purpose, GMDN category —…
- GMDN category: Accelerator system, linear
Intended purpose
The System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.