# K083001: M5 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Oct 22, 2008 after 14 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.
179 later devices descend from it; 4 cite it directly.
0 of 269 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) 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.
- K042540: Philips IU22 Ultrasound System, Philips Ultrasound, Inc. (2004) Summary page 1.

## 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 device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, intraoperative (abdominal, thoracic, and vascular etc.), pediatric, neonatal cephalic, musculoskeletal (general and superficial).

Source page: https://510kreport.com/device/K083001
Methodology: https://510kreport.com/methodology