# K133505: Sonoace R7 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Dec 27, 2013 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: 17 generations back to K924432 (1993). 43 ancestors in all.
98 later devices descend from it; 3 cite it directly.
0 of 142 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 10.
- K130803: Ugeo H70C Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2013) Summary page 1.
- K112339: Accuvix A30 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2011) Summary page 2.
- K101455: Eko 7 Diagnostic Ultrasound System, Medison Co., Ltd. (2010) Summary page 1.
- K122583: Ugeo G60 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2012) Summary page 1.
- K132228: Ugeo PT60A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2013) Summary page 31.
- K113381: Mysono U6 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2011) Summary page 25.

## Most influential descendants
- K150478: A35 Diagnostic Ultrasound System (2015), 97 descendants of its own
- K151663: RS80A Diagnostic Ultrasound System (2015), 96 descendants of its own
- K152962: HS70A Diagnostic Ultrasound System (2015), 90 descendants of its own
- K153529: WS80A Diagnostic Ultrasound System (2016), 89 descendants of its own
- K153408: HM70A Diagnostic Ultrasound System (2015), 65 descendants of its own

## Indications for use
The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trns-rectal, Trams-vaginal. Muscular-Skeletal (Convenitional, Superficial), Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Source page: https://510kreport.com/device/K133505
Methodology: https://510kreport.com/methodology