# K210068: HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Apr 9, 2021 after 88 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: 31 generations back to K924432 (1993). 306 ancestors in all.
No later device cites it as a predicate yet.
0 of 307 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192505: HS50/HS60 Diagnostics Ultrasound System, Samsung Medison Co., Ltd. (2019) Summary page 4.
- K192319: HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2019) Summary page 5.

## 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, Trans-esophageal(Cardiac) and peripheral vessel. It is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients. Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

Source page: https://510kreport.com/device/K210068
Methodology: https://510kreport.com/methodology