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

The eHertz Functional Series Diagnostic Ultrasound System (models C, E, R, S) is a portable, laptop-style ultrasound imaging device intended for general-purpose diagnostic imaging in hospitals and medical clinics. It is used for fetal, abdominal, cardiac, vascular, musculoskeletal, and other diagnostic ultrasound examinations in adults, pregnant women, and pediatric patients by qualified healthcare professionals.

The device uses autocorrelation for color processing and FFT for pulse Doppler processing, supporting linear, convex, phased array, and micro-convex array transducers. It operates in B, M, PWD, CWD, Color Doppler, and combined modes, with features including tissue harmonic imaging, panoramic imaging, TDI, color M, and elastography. Key proprietary features include mFlow (micro blood flow imaging), eSRI (speckle reduction), eTuner (auto image optimization), and eTissue (acoustic speed adjustment).

Testing compliance with ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 14971, IEC62359, IEC62304, IEC62366-1, IEC60601-1-6, NEMA PS 3.1–3.20 (DICOM), and IEC 62133-2 for batteries.

The eHertz device employs the same fundamental ultrasound technology (autocorrelation and FFT processing) and supports the same transducer types and core imaging modes as the predicate M9 Premium system. Although the eHertz lacks some advanced features (3D/4D, contrast imaging, intra-operative modes, some measurement packages), it is less capable but functionally equivalent for its stated indications. Both devices meet identical acoustic output limits (Track 3, Ispta ≤720 mW/cm², MI ≤1.9, TI ≤6.0), use equivalent patient-contact materials meeting ISO 10993-1, and are designed for the same general-purpose diagnostic use in hospital or clinic settings by trained professionals.