# K201990: DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Nov 9, 2020 after 115 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: 23 generations back to K935595 (1995). 189 ancestors in all.
No later device cites it as a predicate yet.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173369: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (2017) Summary page 6.

## Indications for use
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. Modes of operation include: B, M, PW Doppler, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Smart 3D, 4D (Real-time 3D), iScape, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) and Combined mode: B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B.

Source page: https://510kreport.com/device/K201990
Methodology: https://510kreport.com/methodology