# K173595: Shear Wave Quantificational Ultrasound Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Hisky Medical Technologies Co., Ltd.
- Decided: Jun 22, 2018 after 213 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: 15 generations back to K935595 (1995). 107 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123806: Fibroscan, Echosens (2013) Summary page 9.
- K072164: DC-6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 9.

## Most influential descendants
- K200136: Shear Wave Quantificational Ultrasound Diagnostic System (2020), 2 descendants of its own
- 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, Model FT9000, is intended to measure the speed of 50Hz shear wave with 2.5MHz ultrasound wave in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease. Shear Wave Quantificational Ultrasound Diagnostic System, Model 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. Details please refer to the attached pages.

Source page: https://510kreport.com/device/K173595
Methodology: https://510kreport.com/methodology