# K172142: FibroScan 430 Mini+

- Pathway: 510(k) (Traditional)
- Applicant: Echosens
- Decided: Sep 13, 2017 after 58 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: 20 generations back to K935595 (1995). 156 ancestors in all.
No later device cites it as a predicate yet.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160524: FibroScan 530 Compact, Echosens (2016) Summary page 7.

## Indications for use
The FibroScan® 430 Mini+ system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. FibroScan® 430 Mini+ is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The shear wave speed and stiffness, and CAP may be used as an aid to clinical management of adult patients with liver disease. Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.

Source page: https://510kreport.com/device/K172142
Methodology: https://510kreport.com/methodology