Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
Eieling Technology (Shenzhen) LimitedThe Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) is a medical imaging device used in clinical settings to non-invasively measure the stiffness and attenuation properties of liver tissue using ultrasound shear wave elastography. It aids clinicians in the diagnosis and monitoring of liver diseases by providing quantitative elastography metrics in a portable and easy-to-use system.
Intended Use
The Liverscan C is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP) in internal structures of the body, for aiding clinical management and diagnosis of adult patients with liver disease.
Technology
The device uses a 3.5 MHz piezoelectric ultrasound transducer and shear wave elastography techniques to measure shear wave speed and stiffness, along with ultrasound attenuation via the Mobile Attenuation Parameter (MAP). It operates on Windows 10 Embedded OS and features B-mode and transient elastography imaging modes.
Performance
The device underwent non-clinical bench testing for electrical safety, electromagnetic compatibility, usability, software verification, and performance testing per IEC and ISO standards, demonstrating substantial equivalence to the predicate device. No clinical testing was conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/22/2024
2 months - 2
FDA Approval
11/19/2024
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