Vivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound andThe Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also applicable to vascular and general radiology. These systems use ultrasound technology to capture, process, and analyze images of the human body, aiding clinicians in precise measurements and display of ultrasound data. They include features such as 3D imaging, Doppler modes, and AI-assisted tools like Easy Auto EF and Easy AFI LV for enhanced image analysis, improving workflow and diagnostic accuracy for healthcare professionals.
Intended Use
General-purpose ultrasound system specialized for cardiac imaging, intended for use by qualified healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid in hospital and private medical office settings.
Technology
A mobile diagnostic ultrasound system with height-adjustable control panel, color LCD touch panel, and display monitor. It supports a variety of transducers including linear, curved, sector/phased and real-time 3D transducers. The system handles ultrasound signal processing, image storage, network access, and output to other devices. It features advanced software including adaptive contrast enhancement, AI-based auto ROI algorithms, and workflow enhancements like CT fusion live and remote viewing.
Performance
Non-clinical testing showed compliance with relevant safety standards including electrical, biocompatibility, and electromagnetic safety. AI algorithm testing showed high accuracy (average dice score ≥91%) on multi-national, multi-scanner view datasets for automatic left ventricle segmentation. Testing included multiple clinical sites with expert manual annotations as ground truth. Clinical studies were not required to support equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/25/2022
3 months - 2
FDA Approval
7/22/2022
Other devices from GE Medical Systems Ultrasound and
- Vivid iq2020 • 510K
- Vivid E80/ Vivid E90/ Vivid E952020 • 510K
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