# K133329: Ugeo WS80A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Nov 27, 2013 after 29 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). 107 ancestors in all.
102 later devices descend from it; 3 cite it directly.
0 of 210 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112339: Accuvix A30 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2011) Summary page 1.
- K130803: Ugeo H70C Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2013) Summary page 1.
- K103397: Accuvix XG Diagnostic Ultrasound System, Medison Co., Ltd. (2011) Summary page 1.
- K130739: Acuson S2000 and S3000 Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2013) Summary page 1.
- K093563: IU22 Ultrasound System and Transducers, Philips Ultrasound, Inc. (2010) Summary page 2.

## Most influential descendants
- K141620: RS80A Diagnostic Ultrasound System (2014), 101 descendants of its own
- K143089: WS80A 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 UGEO WSSOA Diagnostic Ultrasound System and transducers ame intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Small Organ, Trans-rectal. Trans-vaginal. Muscular-Skeletal (Conventional, Superficial) and Peripheral vessel

Source page: https://510kreport.com/device/K133329
Methodology: https://510kreport.com/methodology