V8 Diagnostic Ultrasound System
Samsung Medison CO., LTD.The V8 Diagnostic Ultrasound System by Samsung Medison is a general-purpose, mobile ultrasound device that captures real-time images and analyzes body fluids across various clinical applications including obstetrics, cardiac, abdominal, and musculoskeletal imaging. It uses multiple imaging modes and some AI-based software features to assist clinicians in diagnosis and measurement, helping improve accuracy and efficiency in medical imaging.
Intended Use
The V8 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. Clinical applications include multiple body regions such as Fetal/Obstetrics, Abdominal, Cardiac, Urology, Musculoskeletal, and more.
Technology
The V8 is a software-controlled, mobile ultrasound system that acquires and displays ultrasound data in multiple modes such as 2D, color Doppler, power Doppler, pulsed wave Doppler, tissue Doppler imaging, elastoscan, and 3D/4D. It includes AI-based features like NerveTrack and UterineAssist to assist in non-invasive image processing and analysis.
Performance
The device underwent evaluations for acoustic output, biocompatibility, software functionality, cleaning and disinfection, electrical/mechanical/electromagnetic safety, and conforms to FDA-recognized standards. It did not require clinical studies for substantial equivalence.
Predicate Devices
No predicate devices specified
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