# K102991: M5 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Oct 22, 2010 after 15 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 117 ancestors in all.
128 later devices descend from it; 8 cite it directly.
0 of 246 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100830: M7/M7T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 1.
- K083001: 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.

## Most influential descendants
- K122010: Z6 Diagnostic Ultrasound System (2012), 109 descendants of its own
- K123185: DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound System (2012), 97 descendants of its own
- K132341: DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems (2013), 96 descendants of its own
- K141010: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System (2014), 83 descendants of its own
- K150080: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S (2015), 79 descendants of its own

## Indications for use
The M5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdomen, gynecology, obstetrics, small parts (breast, testes, thyroid, etc.), pediatrics, transcranial, cardiac, peripheral vascular, urology, orthopedics, intraoperative and musculoskeletal (general and superficial) exams.

Source page: https://510kreport.com/device/K102991
Methodology: https://510kreport.com/methodology