# K100079: Digital Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Well.D Medical Electronics Co., Ltd.
- Decided: Mar 1, 2010 after 48 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: 6 generations back to K934139 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081873: Emp-2100 Full Digital Ultrasound Diagnostic Device, Shenzhen Emperor Electronic Technology Co., Ltd. (2008) Summary page 1.

## Indications for use
WED-3 100 Digital Ultrasound Scanner is intended for diagnostic ultrasound imaging analysis for abdomen, gynecology, obstetric, urology and small-parts. The system is intended to use for the following type of studies: fetal, abdominal, pediatric, small organs, peripheral vascular and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate. The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.

Source page: https://510kreport.com/device/K100079
Methodology: https://510kreport.com/methodology