Device Dossier

X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital

Device Dossier for X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital (X-ray system, diagnostic, fluoroscopic, angiographic,…

Intended purpose

Intended for use on human patients to perform: vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional anad minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures, pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplaties procedures.

TGA Public Summary