# K232895: B-Ultrasound Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical Systems Co.,Ltd
- Decided: May 3, 2024 after 228 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: 7 generations back to K934139 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170856: CMS600P2 B-Ultrasound Diagnostic System, Contec Medical Systems Co.,Ltd (2017) Summary page 7.

## Indications for use
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 (Thyroid, Galactophore, Testis), neonatal cephalic, 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. Modes of operation include B, M, PWD(PW), B+M, 2B, 4B. Please refer to the acoustic output declaration for each transducer in 510(K) Summary.

Source page: https://510kreport.com/device/K232895
Methodology: https://510kreport.com/methodology