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

Intended to assist physicians in analyzing two dimensional X-ray images by creating three dimensional views from sets of two dimensional images created during rotational angiographic runs. Intended to assist in the diagnosis and treatment of endovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations. Also supports measurement of lesion dimensions and anatomical distances.

TGA Public Summary