# K103722: The Sonoace R5 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison Co., Ltd.
- Decided: Jan 5, 2011 after 15 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K924432 (1993). 27 ancestors in all.
103 later devices descend from it; 1 cites it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101829: The Sonoace R3 Diagnostic Ultrasound System, Medison Co., Ltd. (2010) Summary page 1.
- K102065: Sonoace R7 Diagnostic Ultrasound System, Medison Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K113381: Mysono U6 Diagnostic Ultrasound System (2011), 102 descendants of its own
- K132228: Ugeo PT60A Diagnostic Ultrasound System (2013), 101 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
- K133505: Sonoace R7 Diagnostic Ultrasound System (2013), 98 descendants of its own

## Indications for use
The SONOACE R5 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 Organs, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult and Peripheral-vessel.

Source page: https://510kreport.com/device/K103722
Methodology: https://510kreport.com/methodology