# K102865: DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Nov 3, 2010 after 34 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 119 ancestors in all.
No later device cites it as a predicate yet.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101041: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010)
- K091941: DC-3/DC-3T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2009) Summary page 2.
- K102991: M5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010). Cleared while this submission was under review Summary page 2.

## Indications for use
The DC-3/DC-3T diagnostic Ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric. small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial. cardiac, transvaginal, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and MUSCUloskeletal (conventional and superficial) exams.

Source page: https://510kreport.com/device/K102865
Methodology: https://510kreport.com/methodology