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

It is a processing software medical device intended to assist physicians. It receives image data from medical devices, such as, but not limited to, CT and MRI, and image archives. It performs viewing, image manipulation, communication, printing and quantification of images. For example, embolization using interventional X-ray, it provides the user with tools to plan and guide the procedure using 3D image data and reconstructs 3D volumes from rotational fluoroscopic acquisitions, and provides CT-like images that assist the physician with diagnosis, surgical planning, interventional procedures, and treatment follow-up.

TGA Public Summary