# K081320: DC-3, DC-3T Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: May 27, 2008 after 15 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: 12 generations back to K935595 (1995). 89 ancestors in all.
180 later devices descend from it; 2 cite it directly.
0 of 270 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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)

## Most influential descendants
- K083505: DC-3/DC-3T Diagnostic Ultrasound System (2008), 178 descendants of its own
- K091941: DC-3/DC-3T Diagnostic Ultrasound System (2009), 177 descendants of its own
- 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

## 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 fetal -OB/GYN, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transvaginal, transrectal, peripheral vascular, and musculoskeletal (conventional and superficial) exams.

Source page: https://510kreport.com/device/K081320
Methodology: https://510kreport.com/methodology