Device Category Dossier

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

Device Category Dossier for X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital. Australian ARTG records, sponsors, device class —…

Stationary diagnostic fluoroscopic x-ray systems are designed to optimise the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. These devices are used for vascular, cardiovascular and neurovascular imaging applications including diagnostic, interventional and minimally invasive procedures, cardiac imaging, pacemaker implantations, electrophysiology, and non-vascular interventions such as drainages, biopsies and vertebroplasties.