# K140030: DC-N3/DC-N3S Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Feb 19, 2014 after 44 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: 21 generations back to K935595 (1995). 187 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123503: DC-N3/DC-NS3 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2012) Summary page 2.
- K103583: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 3.
- K120699: DC-T6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2012) Summary page 3.
- K101236: Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BM, GE Healthcare (2011) Summary page 3.

## Most influential descendants
- K173369: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System (2017), 2 descendants of its own
- K162845: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System (2016), 1 descendant of its own
- K223917: Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno X2E,Vinno X2P (2023), 0 descendants of its own
- K201990: DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System (2020), 0 descendants of its own
- K183377: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System (2019), 0 descendants of its own

## Indications for use
The DC-N3,DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic (neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.

Source page: https://510kreport.com/device/K140030
Methodology: https://510kreport.com/methodology