Aixplorer

The Aixplorer is a diagnostic ultrasound imaging system classified as a Pulse-Echo Ultrasound Imaging Device (Product Code: IYN). It employs advanced imaging technologies, including UltraFast™ imaging, to acquire high-speed, real-time images of soft tissues and fluid flow within the human body. The system is designed for general-purpose diagnostic applications, including elastography for assessing tissue viscoelasticity. Its primary function is to provide detailed visualisation of internal structures through non-invasive ultrasound techniques.

The Aixplorer is supplied as a reusable medical device intended for use in clinical, research, or diagnostic settings. It operates under sterile conditions when interfaced with disposable transducers and does not require sterilisation of the core system itself. The device is MRI-unsafe and must be used in environments where magnetic resonance imaging is not performed. Authorised for commercial distribution in the United States under FDA 510K clearance (K112255), it adheres to regulatory standards set by the Radiology Advisory Committee (RA). Storage and maintenance follow manufacturer guidelines to ensure optimal performance and compliance with medical imaging protocols.