# K103583: DC-7 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Dec 27, 2010 after 20 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: 17 generations back to K935595 (1995). 118 ancestors in all.
123 later devices descend from it; 8 cite it directly.
0 of 242 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) Summary page 2.
- K091941: DC-3/DC-3T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2009) Summary page 2.
- K061682: GE Voluson E8 Ultrasound System, General Electric Co. (2006) Summary page 2.
- K060542: GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX, General Electric Co. (2006) Summary page 2.
- K032974: GE Logiq 5 Pro or Expert, General Electric Co. (2003) Summary page 2.
- K050240: Modification to Acuson CV70 Cardiovascular System, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.
- K052410: Acuson Sequoia Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.
- K060993: GE Logiq P5 and A5, General Electric Co. (2006) Summary page 2.

## Most influential descendants
- 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
- K121010: M7/M7T Diagnostic Ultrasound System (2012), 107 descendants of its own
- K120699: DC-T6 Diagnostic Ultrasound System (2012), 103 descendants of its own
- K123185: DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound System (2012), 97 descendants of its own

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

Source page: https://510kreport.com/device/K103583
Methodology: https://510kreport.com/methodology