# K251728: Velacur One (LI-1100)

- Pathway: 510(k) (Special)
- Applicant: Sonic Incytes Medical Corp
- Decided: Jun 26, 2025 after 21 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: 24 generations back to K935595 (1995). 160 ancestors in all.
No later device cites it as a predicate yet.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233977: Velacur, Sonic Incytes (2024) Summary page 5.

## Indications for use
Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis. The device is intended to be used in a clinical setting and by trained medical professionals.

Source page: https://510kreport.com/device/K251728
Methodology: https://510kreport.com/methodology