# K150239: FibroScan

- Pathway: 510(k) (Traditional)
- Applicant: Echosens
- Decided: Sep 1, 2015 after 211 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). 76 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 102 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 8.
- K132274: Aixplorer, Supersonic Imagine (2013) Summary page 8.

## 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
- K163082: 6200 Ultrasound System and 6250 Ultrasound System (2017), 9 descendants of its own
- K173291: 6440 Ultrasound System (2018), 8 descendants of its own
- K212035: FibroScan 230 (2021), 5 descendants of its own

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

Source page: https://510kreport.com/device/K150239
Methodology: https://510kreport.com/methodology