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

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls on record, checked 22 Oct 2026.

Model / Reference

eHertz C, eHertz E, eHertz R, eHertz S

Primary DI / UDI-DI

06977210170455

Basic UDI-DI

69772101702017J

510(k) Number

K250228 ↗

FDA Product Code

IYN

EMDN Code

Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 892.1550

Market of Registration

France

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system

  Class II

  FDA 510(k) K261272 Active Cleared 23 Jul 2026

• What types of patients can the eHertz Functional Series Diagnostic Ultrasound System be used to assess, and how does it differ between models?

  The eHertz Functional Series is designed for real-time ultrasound imaging of internal body structures, specifically for fetal, abdominal, and pediatric patients. The system’s four models—eHertz C, eHertz E, eHertz R, and eHertz S—are differentiated by their configurations, which likely cater to varying clinical needs (e.g., portability, advanced imaging features, or specialized probes). However, all models share the same core purpose of non-invasive diagnostic imaging in clinical settings like hospitals and diagnostic centers.

• Is the eHertz Functional Series Diagnostic Ultrasound System reusable, and what does that mean for maintenance and cleaning?

  Yes, the eHertz Functional Series is classified as a reusable medical device. This means it is intended for repeated use across multiple patients, requiring adherence to strict cleaning, disinfection, and maintenance protocols to ensure sterility and functionality between uses. Proper reprocessing is critical to prevent cross-contamination and maintain imaging quality.

• How is the eHertz Functional Series Diagnostic Ultrasound System regulated, and what does that mean for purchasing or using it?

  The system holds both FDA 510(k) clearance and MDR compliance, indicating it meets regulatory requirements for safety and performance in the U.S. and European markets, respectively. This means it has undergone evaluation by the appropriate authorities to confirm its substantial equivalence to legally marketed devices (for FDA) and adherence to EU medical device regulations (for MDR). Purchasers should verify local regulatory compliance before use.

• What does the ‘System, Imaging, Pulsed’ classification mean for how this device is used in clinical settings?

  The ‘System, Imaging, Pulsed’ classification indicates this device is designed to generate ultrasound images using pulsed-wave technology, which is standard for diagnostic imaging. Clinicians use it to visualize internal structures in real-time for diagnostic purposes, such as assessing fetal development, abdominal organs, or pediatric conditions. The pulsed imaging mode ensures precise visualization without continuous energy exposure.