Device Dossier

Leksell Stereotactic System® - Stereotactic surgery system, neurological

Device Dossier for Leksell Stereotactic System® - Stereotactic surgery system, neurological (Stereotactic surgery system, neurological, Class IIa,…

Intended purpose

The intended purpose of Leksell Stereotactic System® is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures; for example deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments. In addition, the coordinate frame is intended to be used for target localization and head fixation during intracranial stereotactic radiosurgery with the Leksell Gamma Knife®.

TGA Public Summary