# K232459: Velacur

- Pathway: 510(k) (Special)
- Applicant: Sonic Incytes
- Decided: Sep 12, 2023 after 28 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). 158 ancestors in all.
2 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)
- K223287: Velacur, Sonic Incytes (2023) Summary page 4.

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

## Indications for use
Velacur 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. The device is intended to be used in a clinical setting and by appropriately trained medical professionals.

Source page: https://510kreport.com/device/K232459
Methodology: https://510kreport.com/methodology