Device Dossier
Electromagnetic device tracking system
Device Dossier for Electromagnetic device tracking system (Electromagnetic device tracking system, Class IIb, sponsor GE Healthcare). ARTG record,…
- GMDN category: Electromagnetic device tracking system
- Sponsor: GE Healthcare
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.