# K182632: HS30 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Jan 8, 2019 after 106 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). 279 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 281 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.

## Most influential descendants
- K202556: HS30 Diagnostic Ultrasound System (2020), 0 descendants of its own

## Indications for use
The HS30 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 Peripheral vessel.

Source page: https://510kreport.com/device/K182632
Methodology: https://510kreport.com/methodology