# K043455: SA8000 SE Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison Co., Ltd.
- Decided: Dec 21, 2004 after 6 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: 6 generations back to K924432 (1993). 13 ancestors in all.
182 later devices descend from it; 5 cite it directly.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013627: Sonoace SA-8000 Diagnostic Ultrasound System, Medison America, Inc. (2001) Summary page 2.
- K031552: Mycolor 202 Diagnostic Ultrasound System and Transducers, Medison America, Inc. (2003) Summary page 1.

## Most influential descendants
- K061213: Sonoace Pico Diagnostic Ultrasound System (2006), 114 descendants of its own
- K100186: Mysono U5 Diagnostic Ultrasound System (2010), 111 descendants of its own
- K102065: Sonoace R7 Diagnostic Ultrasound System (2010), 110 descendants of its own
- K112646: Sonoace R7 Diagnostic Ultrasound System (2011), 108 descendants of its own
- K081676: Sonoace X6 Diagnostic Ultrasound System (2008), 105 descendants of its own

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

Source page: https://510kreport.com/device/K043455
Methodology: https://510kreport.com/methodology