# K053530: Sonoace X4 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison Co., Ltd.
- Decided: Jan 3, 2006 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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 K924432 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012887: SA6000II Diagnostic Ultrasound System, Medison America, Inc. (2001) Summary page 1.
- K043455: SA8000 SE Diagnostic Ultrasound System, Medison Co., Ltd. (2004) Summary page 1.

## Indications for use
Ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K053530
Methodology: https://510kreport.com/methodology