Device Dossier

Opticross 6 HD 60 MHz Coronary Imaging Catheter - Ultrasound system, imaging, cardiovascular

Device Dossier for Opticross 6 HD 60 MHz Coronary Imaging Catheter - Ultrasound system, imaging, cardiovascular (Ultrasound system, imaging,…

Intended purpose

This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Functional description

OptiCross 6 HD ia a sterile, short rail imaging catheter that consists of two main assemblies, an imaging core & a catheter body. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 60 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end of the catheter makes the connection to the Motordrive Unit

TGA Public Summary