Device Dossier

Electromagnetic device tracking system

Device Dossier for Electromagnetic device tracking system (Electromagnetic device tracking system, Class IIb, sponsor GE Healthcare). ARTG record,…

Intended purpose

The IMACTIS® CT-NAVIGATION system is a stereotaxic accessory for Computed Tomography systems. It displays a simulated image of the interventional instrument on a computer monitor screen that also shows images of the targeted organ(s) and the current and the projected future path of the interventional instrument. The IMACTIS® CT-NAVIGATION system is used with linear instruments including but not limited to biopsy needle, aspiration needle, anesthesia needle, ablation needle. The system supports a workflow based on automated image registration of spatial mapping from image space to physical space. The system is intended for intra-operative guidance during percutaneous interventional procedure. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures.

TGA Public Summary