# K113381: Mysono U6 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Dec 29, 2011 after 43 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: 14 generations back to K924432 (1993). 29 ancestors in all.
102 later devices descend from it; 2 cite it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112646: Sonoace R7 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2011) Summary page 2.
- K093714: Sonoace X8 Diagnostic Ultrasound System, Medison Co., Ltd. (2009) Summary page 1.
- K100186: Mysono U5 Diagnostic Ultrasound System, Medison Co., Ltd. (2010) Summary page 2.
- K103722: The Sonoace R5 Diagnostic Ultrasound System, Medison Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K132228: Ugeo PT60A Diagnostic Ultrasound System (2013), 101 descendants of its own
- K142466: UGEO PT60A Diagnostic Ultrasound System (2014), 99 descendants of its own
- K143264: H60 V2.00 Diagnostic Ultrasound System (2014), 98 descendants of its own
- K133505: Sonoace R7 Diagnostic Ultrasound System (2013), 98 descendants of its own
- K150478: A35 Diagnostic Ultrasound System (2015), 97 descendants of its own

## Indications for use
The MySono U6 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Source page: https://510kreport.com/device/K113381
Methodology: https://510kreport.com/methodology