# K242496: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)

- Pathway: 510(k) (Traditional)
- Applicant: Eieling Technology (Shenzhen) Limited
- Decided: Nov 19, 2024 after 89 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K935595 (1995). 164 ancestors in all.
No later device cites it as a predicate yet.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233401: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile), Eieling Technology Limited (2024) Summary page 5.

## Indications for 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: Mobile Attenuation Parameter) in internal structures of the body. The shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease. The Liverscan C is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter). The shear wave speed and stiffness, and MAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver. This device is designed to be used in a doctor's office to measure the stiffness and ultrasonic attenuation of the liver in patients with liver disease. It does so in a painless and completely non-invasive manner. To ensure safe and effective operation,the operator shall meet the following requirements: 1) Receive training as required by local,state and national regulations,if applicable 2) Receive additional training as required by the authorized distributor or EIELING 3) Has a thorough knowledge and understanding of the material presented in this manual

Source page: https://510kreport.com/device/K242496
Methodology: https://510kreport.com/methodology