# K201597: Liver Incytes, Model 1005

- Pathway: 510(k) (Traditional)
- Applicant: Sonic Incytes
- Decided: Jul 31, 2020 after 49 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: 20 generations back to K935595 (1995). 156 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160524: FibroScan 530 Compact, Echosens (2016) Summary page 5.

## Most influential descendants
- K223287: Velacur (2023), 3 descendants of its own
- K232459: Velacur (2023), 2 descendants of its own
- K233977: Velacur (2024), 1 descendant of its own
- K251728: Velacur One (LI-1100) (2025), 0 descendants of its own

## Indications for use
The Liver Incytes System is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz) and coefficient of attenuation. The device is indicated to non-invasively determine liver tissue stiffness and attenuation. These are meant to be used in conjunction with other clinical indicators in order to assist in clinical management of patients with liver disease.

Source page: https://510kreport.com/device/K201597
Methodology: https://510kreport.com/methodology