# K250228: eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E,  eHertz R, eHertz S)

- Pathway: 510(k) (Traditional)
- Applicant: Esonic Technology (Wuhan) Co., Ltd.
- Decided: Apr 23, 2025 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: 29 generations back to K935595 (1995). 359 ancestors in all.
No later device cites it as a predicate yet.
6 of 360 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230768: M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2023) Summary page 5.

## Indications for use
The eHertz Functional Series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), trans-rectal, trans-vaginal, musculoskeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Panoramic Imaging, TDI, Color M, Elastography.

Source page: https://510kreport.com/device/K250228
Methodology: https://510kreport.com/methodology