Device Dossier

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

Device Dossier for X-ray system, diagnostic, fluoroscopic, angiographic, application program software (X-ray system, diagnostic, fluoroscopic,…

Intended purpose

Assists during endovascular procedures for treating of saccular cerebral aneurysms, by: •Visualization of blood flow patterns in the aneurysm and parent vessel, based on digital subtraction angiography •Quantification of the blood flow in theaneurysm parent vessel, based on digital subtraction angiography and 3D rotational angiography. •Comparison of blood flow, both visual and quantified between two acquisitions.

TGA Public Summary