eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)
eSonic Technology (Wuhan) Co., LTDThe eHertz Functional Series Diagnostic Ultrasound System by eSonic Technology is a portable ultrasound imaging device designed for general diagnostic use across adults, pregnant women, and pediatric patients. It supports multiple imaging modes including B-mode, Doppler, and elastography among others, enabling healthcare professionals to visualize and analyze the human body and fluid for various exams such as fetal, abdominal, cardiac, and musculoskeletal. This system enhances image quality through features like micro blood flow imaging and image optimization, aiding clinicians in making more accurate assessments.
Intended Use
The eHertz Functional Series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and 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 as a general purpose diagnostic ultrasound system for imaging, measurement, display and analysis of human body and fluid.
Technology
The eHertz system is a Track 3 diagnostic ultrasound device featuring electronics for ultrasound signal transmit/receive, processing, and software controls. It supports multiple imaging modes including Doppler and elastography, uses linear, convex, and phased array transducers, and incorporates proprietary image optimization technologies such as mFlow (micro blood flow imaging), eSRI (post-processing to reduce noise and speckle), and eTuner (automatic B-mode image gain adjustment).
Performance
The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and passed tests for thermal, electrical, electromagnetic, mechanical safety, and complies with standards such as ANSI/AAMI ES60601, IEC60601 series, ISO10993, and DICOM. Non-clinical testing supports substantial equivalence to the predicate device, with no clinical studies required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/27/2025
2 months - 2
FDA Approval
4/23/2025
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