# K170856: CMS600P2 B-Ultrasound Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical Systems Co.,Ltd
- Decided: Nov 17, 2017 after 240 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.
1 later device descends from it; 1 cites it directly.
0 of 20 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 10.

## Most influential descendants
- K232895: B-Ultrasound Diagnostic System (2024), 0 descendants of its own

## Indications for use
CMS600P2 B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen,gynecology, obstetric, urology,and small-parts application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, 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. Please refer to the acoustic output declaration for each transducer as following pages.

Source page: https://510kreport.com/device/K170856
Methodology: https://510kreport.com/methodology