# K191055: HS40 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Jun 12, 2019 after 54 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: 30 generations back to K924432 (1993). 358 ancestors in all.
9 later devices descend from it; 1 cites it directly.
6 of 368 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180409: HS40 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2018) Summary page 5.
- K181336: HS50 / HS60 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2018) Summary page 22.
- K133505: Sonoace R7 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2013) Summary page 21.
- K182894: HM70A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2019) Summary page 19.

## Most influential descendants
- K200339: HS40 Diagnostic Ultrasound System (2020), 8 descendants of its own
- K210713: HM70 EVO Diagnostic Ultrasound System (2021), 4 descendants of its own
- K220269: HM70 EVO Diagnostic Ultrasound System (2022), 3 descendants of its own
- K233112: HM70 EVO Diagnostic Ultrasound System (2023), 2 descendants of its own
- K254099: EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System (2026), 1 descendant of its own

## Indications for use
The HS40 ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. 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 Peripheral vessel.

Source page: https://510kreport.com/device/K191055
Methodology: https://510kreport.com/methodology