# K210154: Labat series Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Wisonic Medical Technology Co., Ltd.
- Decided: Jul 30, 2021 after 190 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: 27 generations back to K935595 (1995). 249 ancestors in all.
No later device cites it as a predicate yet.
0 of 250 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180912: TE7/TE5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2018) Summary page 5.

## Indications for use
The Labat series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small organ (breast, thyroid, testes,etc.), neonatal cephalic, adult cephalic, trans-vaginal, trans-rectal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), trans-esoph.(cardiac), peripheral vessel and urology exams. The operator for Labat series Diagnostic Ultrasound System is intended for professional clinical staff or the qualified and trained personnel with experience in the use of ultrasound diagnostic equipment. The device is intended to be used in hospital or clinics. Modes of operation include: B-Mode, M-Mode, Color Mode, Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging, Anatomic M and combined mode.

Source page: https://510kreport.com/device/K210154
Methodology: https://510kreport.com/methodology