# K101041: DC-7 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Apr 30, 2010 after 16 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: 16 generations back to K935595 (1995). 116 ancestors in all.
130 later devices descend from it; 4 cite it directly.
0 of 247 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092691: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2009) Summary page 1.
- K091941: DC-3/DC-3T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2009) Summary page 1.
- K060993: GE Logiq P5 and A5, General Electric Co. (2006) Summary page 1.
- K041688: GE Voluson 730 Pro/Expert Untrasound BT04, General Electric Co. (2004) Summary page 1.

## Most influential descendants
- K103677: M7/M7T Diagnostic Ultrasound System (2011), 123 descendants of its own
- K103583: DC-7 Diagnostic Ultrasound System (2010), 123 descendants of its own
- K110199: DC-T6 Diagnostic Ultrasound System (2011), 117 descendants of its own
- K113647: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System (2011), 116 descendants of its own
- K122010: Z6 Diagnostic Ultrasound System (2012), 109 descendants of its own

## Indications for use
The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, pediatric, neonatal cephalic, musculoskeletal(conventional and superficial), intraoperative and transcranial exams.

Source page: https://510kreport.com/device/K101041
Methodology: https://510kreport.com/methodology