Device Dossier

Coronary optical coherence tomography system

Device Dossier for Coronary optical coherence tomography system (Coronary optical coherence tomography system, Class IIa, sponsor Abbott Medical). ARTG…

Intended purpose

For qualitative and quantitative evaluation of vascular morphology in the coronary arteries. As an adjunct to conventional angiographic procedure to provide an image of vessel lumen and wall structures. For imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedure. To compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

TGA Public Summary