# K103677: M7/M7T Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jan 31, 2011 after 46 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: 17 generations back to K935595 (1995). 165 ancestors in all.
123 later devices descend from it; 6 cite it directly.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101041: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.
- K060542: GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX, General Electric Co. (2006) Summary page 2.
- K093563: IU22 Ultrasound System and Transducers, Philips Ultrasound, Inc. (2010) Summary page 2.
- K050240: Modification to Acuson CV70 Cardiovascular System, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 2.
- K072365: Sequoia Plus Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 2.
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4, GE Healthcare (2009) Summary page 2.
- K061682: GE Voluson E8 Ultrasound System, General Electric Co. (2006) Summary page 2.
- K091374: GE Logiq I/E & Vivid E Compact Ultrasound, Ge Medical Systems China Co., Ltd. (2009) Summary page 2.

## Most influential descendants
- K113647: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System (2011), 116 descendants of its own
- K121010: M7/M7T Diagnostic Ultrasound System (2012), 107 descendants of its own
- K120699: DC-T6 Diagnostic Ultrasound System (2012), 103 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

## 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), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

Source page: https://510kreport.com/device/K103677
Methodology: https://510kreport.com/methodology