# K232908: Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical Systems Co.,Ltd
- Decided: May 2, 2024 after 226 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: 29 generations back to K935595 (1995). 295 ancestors in all.
No later device cites it as a predicate yet.
6 of 296 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213862: HD60 Series Ultrasound Diagnostic System, Qingdao Hisense Medical Equipment Co., Ltd. (2022) Summary page 7.

## Indications for use
The Color Doppler Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment. The systems support the following clinical applications: Ultrasound examination and diagnosis of abdomen, obstetrics, gynecology, small organ (Thyroid, Galactophore, Testis) and cardiac. Modes of operation include: 3D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

Source page: https://510kreport.com/device/K232908
Methodology: https://510kreport.com/methodology