Vivid T8, Vivid T9
GE Medical Systems Ultrasound and Primary Care Diagnostics,The Vivid T8 and Vivid T9 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also supporting vascular and general radiology applications. They provide digital acquisition, processing, analysis, and image display, and incorporate AI algorithms such as Easy Auto EF and Easy AFI LV that assist clinicians by automating measurements and analysis of cardiac function, improving workflow and diagnostic accuracy.
Intended Use
The Vivid T8/Vivid T9 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid in various clinical settings.
Technology
The system includes a mobile console with control panel, multiple types of electronic array transducers, digital acquisition, image processing, and analysis capabilities. It supports various imaging modes including B, M, PW Doppler, CW Doppler, color and power Doppler, harmonic imaging, and coded pulse. It incorporates AI algorithms such as Easy Auto EF and Easy AFI LV which provide automated ROI detection using AI-based segmentation, enhancing workflow and diagnostic capability.
Performance
Non-clinical testing includes compliance with multiple safety standards and device verification through unit and integration testing. AI performance testing shows an average dice score of 91-92% or higher for automated ROI segmentation on diverse datasets from multiple countries. The testing datasets were independently collected and annotated by cardiologists with consensus review. No clinical studies were required for this submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/20/2022
2 months - 2
FDA Approval
7/18/2022
Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics,
- Vivid Pioneer2025 • 510K
- Versana Premier; Versana Premier Lotus; LOGIQ F2024 • 510K
- Voluson Signature 20, Voluson Signature 182024 • 510K
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