# K100186: Mysono U5 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison Co., Ltd.
- Decided: Mar 24, 2010 after 61 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: 8 generations back to K924432 (1993). 19 ancestors in all.
111 later devices descend from it; 3 cite it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063580: Sonoace X8 Diagnostic Ultrasound System, Medison Co., Ltd. (2006) Summary page 1.
- K061213: Sonoace Pico Diagnostic Ultrasound System, Medison Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K102065: Sonoace R7 Diagnostic Ultrasound System (2010), 110 descendants of its own
- K112646: Sonoace R7 Diagnostic Ultrasound System (2011), 108 descendants of its own
- K103722: The Sonoace R5 Diagnostic Ultrasound System (2011), 103 descendants of its own
- K113381: Mysono U6 Diagnostic Ultrasound System (2011), 102 descendants of its own
- K132228: Ugeo PT60A Diagnostic Ultrasound System (2013), 101 descendants of its own

## Indications for use
The MySono U5Ssystem and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Abdomen, Obstetrics, Gynecology, Musculoskeletal, Small Parts, Vascular, Cardiac, Pediatric Cardiology, TCD and Urology applications.

Source page: https://510kreport.com/device/K100186
Methodology: https://510kreport.com/methodology