# K171070: WS80A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Aug 9, 2017 after 121 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). 228 ancestors in all.
42 later devices descend from it; 3 cite it directly.
0 of 271 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153529: WS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2016) Summary page 4.
- K162094: RS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2016) Summary page 29.
- K142472: Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems, GE Healthcare (2015) Summary page 31.

## 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
The WS80A 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, Intra-operative, 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/K171070
Methodology: https://510kreport.com/methodology