# K211886: Clivia series Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Wisonic Medical Technology Co., Ltd.
- Decided: Dec 2, 2021 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: 24 generations back to K935595 (1995). 196 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180599: Venue, GE Medical Systems Ultrasound and Primary Care Diagnostics (2018) Summary page 5.

## Most influential descendants
- K230066: Carnation series Diagnostic Ultrasound System (2023), 0 descendants of its own

## Indications for use
The Clivia series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, Abdominal/GYN, Pediatrics, Small Organ(breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric), peripheral vessel and Urology exams. The operator for Clivia 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, 3D/4D, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M(AMM) and combined mode.

Source page: https://510kreport.com/device/K211886
Methodology: https://510kreport.com/methodology