# K153539: RS80A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Oct 3, 2016 after 298 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: 22 generations back to K924432 (1993). 213 ancestors in all.
59 later devices descend from it; 1 cites it directly.
0 of 273 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151663: RS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2015) Summary page 20.
- K140639: Prosound F75  Diagnostic Ultrasound System, Hitachi Aloka Medical, Ltd. (2014) Summary page 27.

## Most influential descendants
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K173204: RS85 Diagnostic Ultrasound System (2018), 39 descendants of its own
- K170493: HS50 / HS60 Diagnostic Ultrasound System (2017), 37 descendants of its own
- K172129: HS40 Diagnostic Ultrasound System (2017), 35 descendants of its own
- K180409: HS40 Diagnostic Ultrasound System (2018), 34 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/K153539
Methodology: https://510kreport.com/methodology