# K203273: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)

- Pathway: 510(k) (Traditional)
- Applicant: Echosens
- Decided: Mar 25, 2021 after 139 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: 22 generations back to K935595 (1995). 161 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181547: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+), Echosens (2018) Summary page 4.

## Most influential descendants
- K212035: FibroScan 230 (2021), 5 descendants of its own
- K213102: ES1 System (2022), 3 descendants of its own
- K233401: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) (2024), 2 descendants of its own
- K232336: ES Series V2 (2023), 2 descendants of its own
- K223902: FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) (2023), 1 descendant of its own

## Indications for use
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) 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® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) 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. FibroScan® 630 (Expert) is also indicated for noninvasive measurement in the spleen of 100 Hz shear wave speed and estimates of stiffness that may be used as an aid to diagnosis, monitoring and clinical management of adult patients with liver disease, as part of an overall assessment of the liver. *CAP for pediatric patients with liver disease is only available with SmartExam capability on FibroScan® Models: 530 Compact, 430 Mini+, and 630

Source page: https://510kreport.com/device/K203273
Methodology: https://510kreport.com/methodology