# K132861: Ugeo H60 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Oct 4, 2013 after 22 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: 17 generations back to K924432 (1993). 27 ancestors in all.
102 later devices descend from it; 3 cite it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122583: Ugeo G60 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2012) Summary page 1.
- K130803: Ugeo H70C Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2013) Summary page 1.

## Most influential descendants
- K143089: WS80A Diagnostic Ultrasound System (2014), 99 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
- K150478: A35 Diagnostic Ultrasound System (2015), 97 descendants of its own
- K151663: RS80A Diagnostic Ultrasound System (2015), 96 descendants of its own

## Indications for use
The UOEO 1-160 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 and Peripheral vessel

Source page: https://510kreport.com/device/K132861
Methodology: https://510kreport.com/methodology