# K181336: HS50 / HS60 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Dec 4, 2018 after 197 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: 29 generations back to K924432 (1993). 291 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 323 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170493: HS50 / HS60 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2017) Summary page 5.
- K173204: RS85 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2018) Summary page 22.
- K173513: WS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2018) Summary page 24.
- K180409: HS40 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2018) Summary page 23.

## Most influential descendants
- K192903: RS85 Diagnostic Ultrasound System (2020), 21 descendants of its own
- K211945: V8 Diagnostic Ultrasound System (2021), 13 descendants of its own
- K220975: V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (2022), 12 descendants of its own
- K223387: V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (2023), 11 descendants of its own
- K192505: HS50/HS60 Diagnostics Ultrasound System (2019), 10 descendants of its own

## Indications for use
The HS50 / HS60 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, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Trans-esophageal(Cardiac), and peripheral vessel.

Source page: https://510kreport.com/device/K181336
Methodology: https://510kreport.com/methodology