# K230066: Carnation series Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Wisonic Medical Technology Co., Ltd.
- Decided: Sep 15, 2023 after 249 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). 399 ancestors in all.
No later device cites it as a predicate yet.
6 of 400 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 4.
- K173471: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2018) Summary page 4.
- K211886: Clivia series Diagnostic Ultrasound System, Shenzhen Wisonic Medical Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
The Carnation 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 and superficial), cardiac (adult and pediatric), peripheral vessel, urology, Thoracic/Pleural, Vascular Access exams. The Carnation series Diagnostic Ultrasound System is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Carnation series can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients. 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(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode.

Source page: https://510kreport.com/device/K230066
Methodology: https://510kreport.com/methodology