# K250026: Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Hisky Medical Technologies Co., Ltd.
- Decided: Oct 1, 2025 after 268 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K935595 (1995). 192 ancestors in all.
No later device cites it as a predicate yet.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200136: Shear Wave Quantificational Ultrasound Diagnostic System, Wuxi Hisky Medical Technologies Co., Ltd. (2020) Summary page 6.

## Indications for use
Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device, is intended to provide 50 Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device is intended to provide 100Hz shear wave speed measurements and estimates of tissue stiffness in spleen. Shear Wave Quantificational Ultrasound Diagnostic System is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile. Shear Wave Quantificational Ultrasound Diagnostic System is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis in the human body (including abdominal applications) in B, M, CFM, PWD, B/B, 4B, B+M, B+CFM, B+PWD, and B+CFM+PWD modes. The system must be operated by qualified and appropriately trained medical professionals in a professional healthcare facility environment.

Source page: https://510kreport.com/device/K250026
Methodology: https://510kreport.com/methodology