# K201988: T-Lite

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscanner
- Decided: Oct 30, 2020 after 105 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: 20 generations back to K935595 (1995). 133 ancestors in all.
1 later device descends 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)
- K171164: U-Lite EXP, Sonoscanner (2017) Summary page 4.

## Most influential descendants
- K232285: U-Lite PRO (2024), 0 descendants of its own

## Indications for use
The T-Lite ultrasound system is intended for use by an appropriately-trained healthcare professional. We recommend that all users receive proper training by an authorized Sonoscanner representative before attempting to use the scanner. You must also follow corresponding local government rules and guidelines at all times. T-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, musculoskeletal (both conventional and superficial), neonatal cephalic NOTE : The application fields are dependent on the selected probe. NOTE : T-Lite is a general-purpose ultrasound. It can therefore be used in different configurations, especially: - in medical offices, - in clinics, - in hospitals. It is used in imaging or examination rooms. It can be used at the bedside. It is not intended for direct use in a sterile environment. NOTE : The T-Lite is not compatible with the use of the HF surgery device or in an MRI system. Modes of operation include: * B-Mode * B-Mode + M-Mode * B-Mode + Color Doppler * B-Mode + Power Doppler « Spectral Pulsed-Wave Doppler

Source page: https://510kreport.com/device/K201988
Methodology: https://510kreport.com/methodology