# K232285: U-Lite PRO

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscanner Sarl
- Decided: Jan 11, 2024 after 164 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: 21 generations back to K935595 (1995). 134 ancestors in all.
No later device cites it as a predicate yet.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201988: T-Lite, Sonoscanner (2020) Summary page 6.

## Indications for use
U-Lite PRO is a Handheld Ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals. It can therefore be used in different configurations, especially: - In medical offices (general practitioner's office) - In clinics & hospitals (incl. in emergency and critical care units) - In a field hospital It is used in imaging or examinations rooms. It can be used at the bedside. It is not intended for direct use in a sterile environment. The U-Lite PRO is not compatible with the use of the HF surgery device or in an MRI system. U-Lite PRO 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: • ophthalmic • fetal/obstetric, • gynecological, • abdominal, • pediatric, • neonatal cephalic • adult cephalic • small organ, • trans-vaginal, • trans-rectal, • cardiac adult & pediatric • peripheral vascular, • urology (including prostate) • musculoskeletal (both conventional and superficial) Note : The application fields are dependent on the selected probes and the modes of operations. Modes of operations include: • B-Mode (B) • M-Mode (M) • Color Doppler (CD) • Power Doppler (PD) • Spectral Pulsed-Wave Doppler (PWD) • Continous Wave Doppler (CWD) • Combined :(B+M; B+CD; B+ PD; B+PWD)

Source page: https://510kreport.com/device/K232285
Methodology: https://510kreport.com/methodology