X-ray system, diagnostic, fluoroscopic, angiographic, application program software

Intended purpose

Assists physicians during vascular and non-vascular procedures, with diagnosis, treatment planning, interventional procedures and treatment follow-up by creating 3D views from sets of 2D images created during rotational acquisitions. Provides high-speed and high-resolution 3D visualizations of vasculature, hemorrhages, soft tissue and bone structures. Provides live image guidance for navigating endovascular devices through vascular structures anywhere in the body. Helps to assess anatomical information intra-procedurally, such as the estimate of a vessel or lesion size, diameter or volume, and anatomical distances between relevant structures. Intended to be used for human patients that have been elected for the procedures as described in these Indications for Use.