# K212035: FibroScan 230

- Pathway: 510(k) (Special)
- Applicant: Echosens
- Decided: Jul 30, 2021 after 30 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: 23 generations back to K935595 (1995). 162 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 168 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.

## Most influential descendants
- K233401: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) (2024), 2 descendants of its own
- K223902: FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) (2023), 1 descendant of its own
- K260748: ES-Series (2026), 0 descendants of its own
- K253221: Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (2026), 0 descendants of its own
- K242496: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (2024), 0 descendants of its own

## Indications for use
The FibroScan® 230 is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. The shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease. The FibroScan® 230 is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 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, and CAP may be used as an aid in the clinical management of pediatric patients with liver disease.

Source page: https://510kreport.com/device/K212035
Methodology: https://510kreport.com/methodology