# K171048: RS80A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Aug 24, 2017 after 139 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: 25 generations back to K924432 (1993). 233 ancestors in all.
50 later devices descend from it; 3 cite it directly.
0 of 284 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162094: RS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2016) Summary page 30.
- K121223: Qlab with FHN and VPQ Plug-in, Philips Ultrasound, Inc. (2012) Summary page 30.
- K142160: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2014) Summary page 30.
- K142368: Noblus Diagnostic Ultrasound Scanner, Hitachi Aloka Medical, Ltd. (2015) Summary page 30.

## Most influential descendants
- K173204: RS85 Diagnostic Ultrasound System (2018), 39 descendants of its own
- K173513: WS80A Diagnostic Ultrasound System (2018), 32 descendants of its own
- K181336: HS50 / HS60 Diagnostic Ultrasound System (2018), 31 descendants of its own
- K182595: HERA W10 Diagnostic Ultrasound System (2018), 26 descendants of its own
- K182932: RS85 Diagnostic Ultrasound System (2019), 24 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K171048
Methodology: https://510kreport.com/methodology