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 to perform: - Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedures. - Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally, can be used in a hybrid operating room and contains a number of features to support a flexible and patient-centric procedural workflow.

TGA Public Summary