# K142511: U50 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 20, 2015 after 165 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). 126 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123249: Diagnostic Ultrasound System, Edan Instruments, Inc. (2013) Summary page 16.
- K072164: DC-6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 16.
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2, Ge Medical Systems Ultrasound and Primary Care Dia (2008) Summary page 16.

## Most influential descendants
- K161300: Acclarix AX8 Diagnostic Ultrasound System (2016), 9 descendants of its own
- K162055: Acclarix LX8 Diagnostic Ultrasound System (2017), 8 descendants of its own
- K171824: Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System (2017), 7 descendants of its own
- K180862: Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System (2018), 3 descendants of its own
- K171900: Acclarix AX4 Diagnostic Ultrasound System (2017), 2 descendants of its own

## Indications for use
The diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients’ ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

Source page: https://510kreport.com/device/K142511
Methodology: https://510kreport.com/methodology