Device Dossier
Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal
Device Dossier for Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal (Transducer assembly, ultrasound, diagnostic, intracorporeal,…
Intended purpose
An ultrasound imaging transducer assembly enclosed in a fluid-resistant, acoustically- and electrically-insulated housing, designed to be inserted and positioned in the oesophagus to obtain ultrasound images of the heart and/or to navigate devices requiring ultrasound guidance and placement (e.g., endoscopy equipment or needle biopsy equipment). Also known as an oesophageal endosonography probe or transducer, it is composed of either a single transducer element or an array of transducer elements, i.e., piezoelectric element(s), active element(s), or crystal(s), and associated damping, backing, and matching layer materials. This is a reusable device.