# K121010: M7/M7T Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Apr 19, 2012 after 16 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: 19 generations back to K935595 (1995). 181 ancestors in all.
107 later devices descend from it; 3 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)
- K103677: M7/M7T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2011) Summary page 2.
- K103583: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.
- K113647: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2011) Summary page 2.
- K093563: IU22 Ultrasound System and Transducers, Philips Ultrasound, Inc. (2010) Summary page 2.

## Cited in the summary but kept off the family tree
- K03218: Logiq 7. Number could not be read Summary page 2.

## Most influential descendants
- K132341: DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems (2013), 96 descendants of its own
- K131690: M7/M7T Diagnostic Ultrasound System (2013), 92 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
- K150204: DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems (2015), 71 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), intraoperative and transesophageal (cardiac) exams.

Source page: https://510kreport.com/device/K121010
Methodology: https://510kreport.com/methodology