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 the physician during percutaneous coronary interventions. Provides real-time enhanced visualization of stents and provides real-time enhanced visualization of stents in relation to coronary vessels. Assists in the treatment of cardiovascular diseases by visualizing the placement and deployment of coronary stents. Suitable for use with the entire adult human population. Is a software as a medical deice and does not come in contact with a human subject.

TGA Public Summary