# K190444: HERA I10 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: May 22, 2019 after 86 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: 28 generations back to K924432 (1993). 276 ancestors in all.
No later device cites it as a predicate yet.
0 of 277 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182595: HERA W10 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2018) Summary page 5.

## Indications for use
The 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/K190444
Methodology: https://510kreport.com/methodology