# K132228: Ugeo PT60A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Aug 20, 2013 after 34 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K924432 (1993). 41 ancestors in all.
101 later devices descend from it; 2 cite it directly.
0 of 143 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.
- K113381: Mysono U6 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2011) Summary page 1.
- K101757: Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System, Sonosite,Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- K151663: RS80A Diagnostic Ultrasound System (2015), 96 descendants of its own

## Indications for use
The UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Small Organ, Adult Cephalic, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult. Cardiac Pediatric and Peripheral vessel. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (C2-5) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (C2-8) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (LN5-12) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (LS6-15) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (PN2-4)

Source page: https://510kreport.com/device/K132228
Methodology: https://510kreport.com/methodology