# K173034: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)

- Pathway: 510(k) (Traditional)
- Applicant: Echosens
- Decided: Nov 14, 2017 after 47 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.
15 later devices descend from it; 1 cites it directly.
0 of 172 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 4.

## Most influential descendants
- K181547: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (2018), 14 descendants of its own
- K203273: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) (2021), 9 descendants of its own
- K212035: FibroScan 230 (2021), 5 descendants of its own
- K213102: ES1 System (2022), 3 descendants of its own
- K233401: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) (2024), 2 descendants of its own

## Indications for use
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) 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® Family of Products (Models: 502 Touch, 530 Compact, and 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 diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver. 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/K173034
Methodology: https://510kreport.com/methodology