# K162094: RS80A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Aug 26, 2016 after 29 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: 24 generations back to K924432 (1993). 225 ancestors in all.
64 later devices descend from it; 4 cite it directly.
0 of 290 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 4.
- K153529: WS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2016) Summary page 9.
- K153408: HM70A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2015) Summary page 29.
- K142160: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2014) Summary page 30.
- K131267: Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10, GE Healthcare (2013) Summary page 30.
- K122536: Amcad-UT Detection Model 2.0, Lin & Associates, LLC (2013) Summary page 30.
- K121223: Qlab with FHN and VPQ Plug-in, Philips Ultrasound, Inc. (2012) Summary page 30.

## Most influential descendants
- 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
- K170493: HS50 / HS60 Diagnostic Ultrasound System (2017), 37 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, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

Source page: https://510kreport.com/device/K162094
Methodology: https://510kreport.com/methodology