# K200136: Shear Wave Quantificational Ultrasound Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Hisky Medical Technologies Co., Ltd.
- Decided: Mar 17, 2020 after 56 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: 22 generations back to K935595 (1995). 191 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173595: Shear Wave Quantificational Ultrasound Diagnostic System, Wuxi Hisky Medical Technologies Co., Ltd. (2018) Summary page 8.
- K181547: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+), Echosens (2018) Summary page 8.

## Most influential descendants
- K250026: Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) (2025), 0 descendants of its own
- K243880: Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) (2025), 0 descendants of its own

## Indications for use
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), Transient Elastography based device, is intended to provide 50Hz 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 (Models: FT9000, FT100 and Mini800), is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as Ultrasound Attenuation Parameter ( UAP ). The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis and monitoring of patients with liver disease, as part of an overall assessment of the liver. Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000), is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal, including location of the liver.

Source page: https://510kreport.com/device/K200136
Methodology: https://510kreport.com/methodology