Device Dossier

N11C5s 9063 Transducer - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical

Device Dossier for N11C5s 9063 Transducer - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical (Transducer assembly, ultrasound,…

Intended purpose

The device is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. It is an intraoperative ultrasound transducer. The indications for use for the 9063 transducer for diagnostic procedures for intraoperative neurosurgical imaging procedures.

Functional description

The N11C5 9063 transducer is a hand held ultrasound transducer designed to be positioned within a surgical site for localised intraoperative applications. The transducers transmit a high frequency harmless sound wave to produce a dynamic image (sonogram) of organs, tissues or blood flow inside the human body. The transducers are designed for reuse and can be sterilised using common sterilisation processes. These can be used in combination with sterile needle guides and with or without a cover.

TGA Public Summary