# K100830: M7/M7T Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: May 5, 2010 after 42 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: 16 generations back to K935595 (1995). 116 ancestors in all.
138 later devices descend from it; 3 cite it directly.
0 of 255 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092691: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2009) Summary page 1.
- K083001: M5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) 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.

## Most influential descendants
- K102991: M5 Diagnostic Ultrasound System (2010), 128 descendants of its own
- K110199: DC-T6 Diagnostic Ultrasound System (2011), 117 descendants of its own
- K113647: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System (2011), 116 descendants of its own
- K122010: Z6 Diagnostic Ultrasound System (2012), 109 descendants of its own
- K121010: M7/M7T Diagnostic Ultrasound System (2012), 107 descendants of its own

## Indications for use
The M7/M7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

Source page: https://510kreport.com/device/K100830
Methodology: https://510kreport.com/methodology