# K160524: FibroScan 530 Compact

- Pathway: 510(k) (Special)
- Applicant: Echosens
- Decided: Mar 18, 2016 after 22 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: 19 generations back to K935595 (1995). 155 ancestors in all.
41 later devices descend from it; 6 cite it directly.
0 of 197 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150949: FibroScan, Echosens (2015) Summary page 7.

## Most influential descendants
- K170445: Logiq S8 (2017), 19 descendants of its own
- K173021: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (2018), 18 descendants of its own
- K180572: AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 (2018), 16 descendants of its own
- K173034: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (2017), 15 descendants of its own
- K181547: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (2018), 14 descendants of its own

## Indications for use
The FibroScan® 530 Compact 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® 530 Compact 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/K160524
Methodology: https://510kreport.com/methodology