Device Dossier

Robot, surgical, navigation unit

Device Dossier for Robot, surgical, navigation unit (Robot, surgical, navigation unit, Class IIb, sponsor Brainlab). ARTG record, intended purpose, GMDN…

Intended purpose

Microscope Navigation is a module, that when used with a Brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to navigated surgery. It links an instrument and the view of the surgical field (e.g. video, view through surgical microscope) to a virtual computer image space on patient image data being processed by the computer. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy.

TGA Public Summary