# K091941: DC-3/DC-3T Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jul 9, 2009 after 9 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: 14 generations back to K935595 (1995). 94 ancestors in all.
177 later devices descend from it; 5 cite it directly.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083505: DC-3/DC-3T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 1.
- K080640: M5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 1.
- K072164: DC-6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.
- K041688: GE Voluson 730 Pro/Expert Untrasound BT04, General Electric Co. (2004) Summary page 1.

## Most influential descendants
- K092691: DC-7 Diagnostic Ultrasound System (2009), 176 descendants of its own
- 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

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of 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/K091941
Methodology: https://510kreport.com/methodology