# K081873: Emp-2100 Full Digital Ultrasound Diagnostic Device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Emperor Electronic Technology Co., Ltd.
- Decided: Jul 16, 2008 after 14 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: 5 generations back to K934139 (1995). 17 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060949: DP-6600 Digital Ultrasonic Diagnostic Imaging System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 2.

## Most influential descendants
- K170856: CMS600P2 B-Ultrasound Diagnostic System (2017), 1 descendant of its own
- K232895: B-Ultrasound Diagnostic System (2024), 0 descendants of its own
- K100079: Digital Ultrasound Scanner (2010), 0 descendants of its own

## Indications for use
EMP-2100 Full Digital Ultrasound Diagnostic System is a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, small-parts, and cardiology application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, 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/K081873
Methodology: https://510kreport.com/methodology