# K200339: HS40 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Apr 7, 2020 after 56 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). 371 ancestors in all.
8 later devices descend from it; 3 cite it directly.
6 of 380 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191055: HS40 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2019) Summary page 5.
- K192505: HS50/HS60 Diagnostics Ultrasound System, Samsung Medison Co., Ltd. (2019) Summary page 23.

## Most influential descendants
- 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
- K210426: HS40 Diagnostic Ultrasound System (2021), 1 descendant of its own

## Indications for use
The HS40 diagnostic ultrasound 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. The HS40 diagnostic ultrasound system 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.

Source page: https://510kreport.com/device/K200339
Methodology: https://510kreport.com/methodology