# K173204: RS85 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Feb 5, 2018 after 126 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: 26 generations back to K924432 (1993). 274 ancestors in all.
39 later devices descend from it; 3 cite it directly.
0 of 314 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171048: RS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2017) Summary page 5.
- K171070: WS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2017) Summary page 5.
- K132274: Aixplorer, Supersonic Imagine (2013) Summary page 28.
- K163691: HS70A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- 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
- K191115: RS85 Diagnostic Ultrasound System (2019), 23 descendants of its own
- K192903: RS85 Diagnostic Ultrasound System (2020), 21 descendants of its own

## Indications for use
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

Source page: https://510kreport.com/device/K173204
Methodology: https://510kreport.com/methodology