Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
Wuxi Hisky Medical Technologies Co., Ltd.The Shear Wave Quantificational Ultrasound Diagnostic System is a portable ultrasound device designed to measure liver tissue stiffness using shear wave elastography and estimate tissue characteristics such as Ultrasound Attenuation Parameter (UAP). It provides non-invasive aid in diagnosing, managing, and monitoring adult and pediatric patients with liver diseases by delivering both ultrasound images and quantitative data on liver health. The system helps clinicians assess liver conditions efficiently and accurately in a clinical setting.
Intended Use
Shear Wave Quantificational Ultrasound Diagnostic System is intended for non-invasive measurement of 50Hz shear wave speed and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal body structures, particularly for aiding clinical management, diagnosis, and monitoring of liver disease in adult and pediatric patients. It also supports general pulse echo ultrasound imaging and Doppler flow analysis, including abdominal imaging to locate the liver.
Technology
The system uses a fibrosis scanning probe with a mechanical vibrator producing 50 Hz shear waves and a convex imaging probe for general purpose ultrasound at 2.5-4.5 MHz. The device measures shear wave speed through transient elastography and ultrasound imaging in B,M, CFM, and PWD modes, combining stiffness measurement with Doppler flow analysis. It is software-controlled and mobile, featuring a single element transducer for elastography and an array probe for imaging, operating with pulse echo ultrasound principles.
Performance
The device underwent extensive non-clinical testing including biocompatibility, reprocessing validation, electromagnetic compatibility, electrical safety, ultrasound performance, software validation, and cybersecurity. The testing demonstrated compliance with relevant ISO standards and FDA guidance documents. Clinical investigation was not applicable due to equivalence to predicate devices with similar performance metrics. The subject device has similar measurement precision and bias for liver stiffness and UAP compared to its predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/18/2024
6 months - 2
FDA Approval
6/17/2025
Other devices from Wuxi Hisky Medical Technologies Co., Ltd.
Ready to Sharpen Your Edge?
Join hundreds of your 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.