Device Category Dossier

Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal

Device Category Dossier for Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal. Australian ARTG records, sponsors, device class —…

Oesophageal ultrasound transducers are imaging transducer assemblies enclosed in a fluid-resistant, acoustically- and electrically-insulated housing, composed of either single or multiple piezoelectric elements with associated damping, backing, and matching layer materials, designed to be inserted into the oesophagus to obtain ultrasound images and navigate devices requiring ultrasound guidance. These devices are used in cardiology applications across neonatal, paediatric and adult patients for general assessment of heart and valve function, cardiac valve assessment, and evaluation of valve lesions and cardiac structures where other imaging modalities may be inconclusive.