# K130803: Ugeo H70C Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Apr 12, 2013 after 21 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: 16 generations back to K924432 (1993). 26 ancestors in all.
106 later devices descend from it; 6 cite it directly.
0 of 133 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 8.
- K122583: Ugeo G60 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2012) Summary page 1.

## Cited in the summary but kept off the family tree
- K113381: Mysono U6 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K133329: Ugeo WS80A Diagnostic Ultrasound System (2013), 102 descendants of its own
- K132861: Ugeo H60 Diagnostic Ultrasound System (2013), 102 descendants of its own
- K141620: RS80A Diagnostic Ultrasound System (2014), 101 descendants of its own
- K143089: WS80A Diagnostic Ultrasound System (2014), 99 descendants of its own
- K142466: UGEO PT60A Diagnostic Ultrasound System (2014), 99 descendants of its own

## Indications for use
The UGEO H7Oc 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/K130803
Methodology: https://510kreport.com/methodology