Device Dossier

N13C5 Transducer, Type 9062 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical

Device Dossier for N13C5 Transducer, Type 9062 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical (Transducer assembly, ultrasound,…

Intended purpose

The device is intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body. It is an intraoperative ultrasound transducer, the indications for use for 9062 is intraoperative neurological imaging as well as spinal cord, intraoperative, and pediatric imaging. The device is reusable.

Functional description

The N13C5 9062 transducer is a hand held ultrasound transducer designed to be positioned within a surgical site for 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 sterilized using common sterilization processes. They can be used in combination with sterile needle guides with or without a cover.

TGA Public Summary