# K183041: Full Digital Colour Doppler Ultrasonic Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Zoncare Bio-medical Electronics Co., Ltd.
- Decided: Jul 10, 2019 after 251 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: 22 generations back to K935595 (1995). 188 ancestors in all.
No later device cites it as a predicate yet.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150999: Acclarix Diagnostic Ultrasound System, Edan Instruments, Inc. (2015) Summary page 10.

## Indications for use
The ZONCARE-M5 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: Abdominal Gynecology(including endovaginal) Obstetric Cardiac Small parts(Breast,Testes,Thyroid,etc.) Urology Musculoskeletal Peripheral vascular

Source page: https://510kreport.com/device/K183041
Methodology: https://510kreport.com/methodology