7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
Esaote, S.P.A.The 7600 Ultrasound System by Esaote is a portable ultrasound imaging device designed for diagnostic ultrasound across multiple clinical domains, including cardiac, vascular, general imaging, and women's health. It supports various ultrasound modes like B-Mode, Doppler, 3D/4D imaging, and elastosonography, enabling detailed visualization and analysis of body structures to aid clinicians in diagnosis and patient care.
Intended Use
The multifunctional ultrasound scanner is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. Main applications include cardiac, vascular, general imaging, and women's health.
Technology
The 7600 Ultrasound System is a portable ultrasound device equipped with multiple LCD displays including a touch panel for control. It operates using ultrasonic pulses above 20 kHz, capturing reflected echoes and Doppler shifts to visualize deep body structures and blood flow velocity. It supports B-Mode, M-Mode, Doppler, Color Flow Mapping, Power Doppler, Elastosonography, 3D/4D imaging, and uses various probe types including phased array and volumetric probes. It implements Microsoft Windows 10 and wireless capabilities.
Performance
The device passed rigorous non-clinical testing standards for safety and performance including electrical safety, electromagnetic compatibility, usability, and acoustic output measurement. Verification and validation testing confirmed all acceptance criteria were met. No additional clinical studies were required to support substantial equivalence.
Predicate Devices
No predicate devices specified
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