Makoto Intravascular Imaging System - Ultrasound system, imaging, cardiovascular

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Nipro Australia Pty Ltd

classe:

Class IIa

Fabriqué par:

Infraredex Inc 28 Crosby Drive Suite 100, Bedford, MA, 01730 United States Of America

Domaine thérapeutique:

40763 - Ultrasound system, imaging, cardiovascular

indications thérapeutiques:

The Makoto Intravascular Imaging System? is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. The System is intended for ultrasound examination of coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Statut de autorisation:

A

Date de l'autorisation:

2022-02-04