# K153529: WS80A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Feb 2, 2016 after 55 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K924432 (1993). 202 ancestors in all.
89 later devices descend from it; 6 cite it directly.
0 of 292 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143089: WS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2014) Summary page 4.
- K152962: HS70A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2015) Summary page 9.
- K151663: RS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2015) Summary page 23.
- K150478: A35 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2015) Summary page 22.
- K122327: Voluson E6/E8/E8EXPERT/E10, GE Healthcare (2012) Summary page 28.
- K142160: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2014) Summary page 28.
- K113758: Voluson E6/E8/E8EXPERT/E10, GE Healthcare (2012) Summary page 29.

## Most influential descendants
- K162094: RS80A Diagnostic Ultrasound System (2016), 64 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K171048: RS80A Diagnostic Ultrasound System (2017), 50 descendants of its own
- K171070: WS80A Diagnostic Ultrasound System (2017), 42 descendants of its own
- K173204: RS85 Diagnostic Ultrasound System (2018), 39 descendants of its own

## Recalls of this device
- Jul 25, 2019 · Class II · Z-2276-2019: There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.

## 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/K153529
Methodology: https://510kreport.com/methodology