# K173003: U50 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Nov 15, 2017 after 49 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: 20 generations back to K935595 (1995). 127 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142511: U50 Diagnostic Ultrasound System, Edan Instruments, Inc. (2015) Summary page 16.

## Most influential descendants
- K180408: U60 Diagnostic Ultrasound System (2018), 0 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/K173003
Methodology: https://510kreport.com/methodology