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510(k) Data Aggregation
K Number
K250228Device Name
eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)
Manufacturer
Date Cleared
2025-04-23
(86 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
eSonic Technology (Wuhan) Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
The proposed eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) are portable, laptop-style ultrasound imaging system used to perform diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, convex, and phased array transducers to produce images, which are displayed on a LED monitor. The eHertz Functional Series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage. The eHertz Functional Series Diagnostic Ultrasound System's software features include mFlow, eSRI, eTuner, eTissue , Steer angle, and 2B/4B, etc.
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