# K131830: Digital Ultrasonic Diagnostic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Sep 17, 2013 after 89 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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.
1 later device descends from it; 1 cites it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102991: M5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 1.
- K072164: DC-6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.
- K123249: Diagnostic Ultrasound System, Edan Instruments, Inc. (2013) Summary page 1.

## Most influential descendants
- K172931: DUS-6000 Digital Ultrasonic Diagnostic Imaging System (2017), 0 descendants of its own

## Indications for use
The diagnostic ultrasound system (DUS 60) is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal; obstetric, gynecology, pediatrics; small parts; urology, peripheral vascular, musculoskeletal (conventional and Superficial), and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional. Diagnostic ultrasound imaging or fluid flow, analysis of the human body as follows: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging, or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K131830
Methodology: https://510kreport.com/methodology