# K143601: U-Lite

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscanner Sarl
- Decided: Mar 18, 2015 after 90 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 131 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133431: VENUE 50, GE Healthcare (2013) Summary page 9.

## Most influential descendants
- K171164: U-Lite EXP (2017), 2 descendants of its own
- K201988: T-Lite (2020), 1 descendant of its own
- K232285: U-Lite PRO (2024), 0 descendants of its own

## Indications for use
U-Lite is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications: fetal/obstetric, gynecological, abdominal, pediatric, small organ, trans-vaginal, trans-rectal, cardiac, peripheral vascular, urology, and musculoskeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K143601
Methodology: https://510kreport.com/methodology