# K123806: Fibroscan

- Pathway: 510(k) (Traditional)
- Applicant: Echosens
- Decided: Apr 5, 2013 after 116 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: 14 generations back to K935595 (1995). 73 ancestors in all.
55 later devices descend from it; 3 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112255: Aixplorer, Supersonic Imagine (2012) Summary page 2.

## Most influential descendants
- K150949: FibroScan (2015), 42 descendants of its own
- K160524: FibroScan 530 Compact (2016), 41 descendants of its own
- K150239: FibroScan (2015), 25 descendants of its own
- K170445: Logiq S8 (2017), 19 descendants of its own
- K173021: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (2018), 18 descendants of its own

## Indications for use
The FibroScan® system is intended to provide 50Hz shear wave speed measurements through internal structures of the body. FibroScan® is indicated for noninvasive measurement of shear wave speed at 50 Hz in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease.

Source page: https://510kreport.com/device/K123806
Methodology: https://510kreport.com/methodology