# K141620: RS80A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Jul 2, 2014 after 15 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: 18 generations back to K924432 (1993). 170 ancestors in all.
101 later devices descend from it; 4 cite it directly.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133329: Ugeo WS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2013) Summary page 1.
- 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 1.
- K103397: Accuvix XG Diagnostic Ultrasound System, Medison Co., Ltd. (2011) Summary page 1.
- K123564: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2012) Summary page 1.
- K050846: B-Cad System, Version 1.0, The Medipattern Corporation (2005) Summary page 1.

## Most influential descendants
- 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
- K152962: HS70A Diagnostic Ultrasound System (2015), 90 descendants of its own

## Indications for use
The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal. Gynecology, Pediatric, Small Organ. Neonatal Cephalic. Adult Cephalic, Trans-rectal, Trans-vaginal. Muscular-Skeletal (Conventional. Superficial), Urology. Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Source page: https://510kreport.com/device/K141620
Methodology: https://510kreport.com/methodology