Device Dossier

Coronary optical coherence tomography system

Device Dossier for Coronary optical coherence tomography system (Coronary optical coherence tomography system, Class IIb, sponsor Abbott Vascular…

Intended purpose

Optical coherence tomography component-based system and its software used with a compatible imaging catheter is intended 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. The system further computes and displays various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

TGA Public Summary