The ES-Series is a portable ultrasound imaging system designed to provide general purpose pulse echo imaging and quantitative tissue characterization. It measures tissue stiffness, brightness parameters, and speed of sound in internal organs, primarily the liver and spleen, aiding healthcare professionals in diagnosis and monitoring of liver diseases in adult and pediatric patients.
Intended Use
General purpose pulse echo ultrasound imaging and soft tissue elasticity imaging of the human body, with measurements of shear wave speed, tissue stiffness, ultrasound tissue brightness parameters, and speed of sound in internal structures. Indicated for imaging anatomical structures in the abdomen and measurement of physical properties in liver and spleen. Intended for use by trained healthcare professionals in healthcare environments.
Technology
The device is a software-based ultrasound imaging system consisting of an external transabdominal ultrasound probe with a mechanical vibrator to produce shear waves, connected via USB-C to an off-the-shelf host running the processing software. The system controls transmit/receive ultrasound sequences, processes raw ultrasound data to produce images and quantitative parameters (elastography, brightness, speed of sound) under real-time 2D imaging guidance. It supports Windows and macOS hosts and includes connectivity to electronic health records using HL7 FHIR standard.
Performance
The device underwent electrical safety testing (IEC 60601-2-37), bench testing on calibrated phantoms to validate signal processing and ultrasound sequences for spleen stiffness, and software verification and validation per FDA guidance. Clinical testing was not required, and testing confirmed the device is substantially equivalent to its predicate with no new safety or effectiveness issues.
Predicate Devices
No predicate devices specified
Ready to Sharpen Your Edge?
Subscribe to join 11k+ peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.