Device Dossier
Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal
Device Dossier for Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal (Transducer assembly, ultrasound, diagnostic, intracorporeal,…
- GMDN category: Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal
- Sponsor: GE Healthcare
Intended purpose
This transesophageal echocardiography endoscope is an invasive medical device entering through the oral cavity. Normal use is either transient (inferior to 60 minutes per 93/42/EEC) or short term (inferior to 30 minutes per 93/42/EEC). It is not intended for long term use (superior to 30 days). This ultrasound probe is not surgically invasive. It is intended to be used on neonate (primary application), paediatric and adult patients for cardiology applications. It is intended to be used for: general assessment of the heart and valves function; cardiac valves assessment; assessment of valve lesions where trans thoracic cardiography may be inconclusive due to poor signal quality; assessment of interatrial septum, left ventricle, left atrial appendage.