Device Category Dossier

Coronary optical coherence tomography system

Device Category Dossier for Coronary optical coherence tomography system. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Coronary optical coherence tomography systems are component-based imaging devices used with compatible imaging catheters to provide qualitative and quantitative evaluation of vascular morphology in the coronary arteries, imaging the vessel lumen and wall structures as an adjunct to conventional angiographic procedures. These systems are indicated for imaging of coronary arteries in patients who are candidates for transluminal interventional procedures.