# K223902: FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)

- Pathway: 510(k) (Traditional)
- Applicant: Echosens
- Decided: Mar 2, 2023 after 64 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: 24 generations back to K935595 (1995). 163 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203273: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630), Echosens (2021) Summary page 4.
- K212035: FibroScan 230, Echosens (2021) Summary page 4.

## Most influential descendants
- K260748: ES-Series (2026), 0 descendants of its own

## Indications for use
The FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is intended to measure liver stiffness (E) using Vibration Controlled Transient Elastography™ (VCTE™) at 50 Hz shear wave frequency and liver ultrasound attenuation coefficient (CAP™)* at 3.5 MHz. FibroScan® 630 Expert is also intended to measure spleen stiffness using VCTE™ at 100 Hz shear wave frequency. FibroScan liver stiffness measurements (LSM) by VCTE™ may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis. FibroScan CAP™ measurements may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis. FibroScan® is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile. The FibroScan® device is intended for use by healthcare professionals in hospitals, clinics or any facility where healthcare is provided. *CAP™ refers to ultrasound attenuation coefficient (originally defined as Controlled Attenuation Parameter). CAP™ on S+ probe is only available with SmartExam capability.

Source page: https://510kreport.com/device/K223902
Methodology: https://510kreport.com/methodology