# K200655: FibroScan® 630

- Pathway: 510(k) (Traditional)
- Applicant: Echosens
- Decided: Jul 16, 2020 after 126 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). 335 ancestors in all.
No later device cites it as a predicate yet.
7 of 336 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 9.
- K173021: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems, Supersonic Imagine (2018) Summary page 9.

## Indications for use
The FibroScan® 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. FibroScan® 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 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.

Source page: https://510kreport.com/device/K200655
Methodology: https://510kreport.com/methodology