# K123249: Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 8, 2013 after 114 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: 18 generations back to K935595 (1995). 125 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110999: Digital Ultrasonic Diagnostic Imaging System, Edan Instruments, Inc. (2011)
- K072164: DC-6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.
- K102991: M5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 1.
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2, Ge Medical Systems Ultrasound and Primary Care Dia (2008) Summary page 1.

## Most influential descendants
- K142511: U50 Diagnostic Ultrasound System (2015), 13 descendants of its own
- K150999: Acclarix Diagnostic Ultrasound System (2015), 12 descendants of its own
- K161300: Acclarix AX8 Diagnostic Ultrasound System (2016), 9 descendants of its own
- K160790: Acclarix LX8 Diagnostic Ultrasound System (2016), 9 descendants of its own
- K162055: Acclarix LX8 Diagnostic Ultrasound System (2017), 8 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), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

Source page: https://510kreport.com/device/K123249
Methodology: https://510kreport.com/methodology