# K080640: M5 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Mar 21, 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: 11 generations back to K935595 (1995). 88 ancestors in all.
182 later devices descend from it; 3 cite it directly.
0 of 271 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072164: DC-6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.
- K061129: GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000, General Electric Co. (2006) Summary page 1.
- K072797: GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact Ultrasound, General Electric Co. (2007) Summary page 1.
- K060949: DP-6600 Digital Ultrasonic Diagnostic Imaging System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K081320: DC-3, DC-3T Diagnostic Ultrasound System (2008), 180 descendants of its own
- K083001: M5 Diagnostic Ultrasound System (2008), 179 descendants of its own
- 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

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of fetal, abdominal, pediatric, neonatal cephalic, cardiac, small parts, transvaginal, transrectal, peripheral-vascular, muscular-skeletal(conventional and superficial).

Source page: https://510kreport.com/device/K080640
Methodology: https://510kreport.com/methodology