# K092691: DC-7 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Oct 15, 2009 after 43 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: 15 generations back to K935595 (1995). 115 ancestors in all.
176 later devices descend from it; 4 cite it directly.
0 of 292 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091941: DC-3/DC-3T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2009). Our OCR of the scanned summary read K091491, FDA’s number for Hero Vascular Access Device (Hemosphere, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Mindray DC-3”.
- K072164: DC-6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.
- K071985: GE Vivid S5 and S6 Diagnostic Ultrasound, General Electric Co. (2007) Summary page 1.
- K090276: Acuson X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.
- K060993: GE Logiq P5 and A5, General Electric Co. (2006) Summary page 1.
- K060542: GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX, General Electric Co. (2006) Summary page 1.

## Most influential descendants
- K100830: M7/M7T Diagnostic Ultrasound System (2010), 138 descendants of its own
- K101041: DC-7 Diagnostic Ultrasound System (2010), 130 descendants of its own
- K102991: M5 Diagnostic Ultrasound System (2010), 128 descendants of its own
- K103677: M7/M7T Diagnostic Ultrasound System (2011), 123 descendants of its own
- K103583: DC-7 Diagnostic Ultrasound System (2010), 123 descendants of its own

## Indications for use
The DC-7 diagnostic ultrasound system is designed for M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e. B/M Mode). The system is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transrectal, transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult). The system includes optional biopsy needle guides that attach to the transducers.

Source page: https://510kreport.com/device/K092691
Methodology: https://510kreport.com/methodology