Vivid T8, Vivid T9
GE Medical Systems Ultrasound and Primary Care DiagnosticsThe Vivid T8 and Vivid T9 are advanced ultrasound imaging systems designed primarily for cardiac imaging but also applicable to vascular and general radiology. These systems provide high-quality ultrasound imaging with various transducer options and include AI-based features that assist clinicians by semi-automating measurements and recognizing Doppler spectra. They support multiple clinical applications in hospital and private settings and enhance diagnostic accuracy and efficiency through AI integration.
Intended Use
The Vivid T9/Vivid T8 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. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices. The systems support multiple clinical applications across fetal/obstetrics, abdominal, pediatric, small organs, neonatal and adult cephalic, cardiac, peripheral vascular, musculoskeletal, and interventional guidance.
Technology
The system consists of a mobile console with color LCD touch panel, LCD display monitor, and optional image storage and printing devices. It includes various electronic array transducers operating in linear, curved, sector/phased array, matrix array, and dual array modes including dedicated continuous wave (CW) transducers. The system leverages ultrasound signal processing software, digital acquisition and analysis, along with network connectivity via wired LAN or wireless LAN using a USB-adapter. It employs AI-based features such as AI Auto Measure for 2D cardiac images and spectrum recognition, as well as automated strain analysis tools for left ventricle, right ventricle, and left atrium, enhancing cardiac functional assessments.
Performance
The device underwent extensive non-clinical testing including acoustic output evaluation, biocompatibility, safety standards compliance (electrical, thermal, electromagnetic, mechanical), and conformity with voluntary international standards such as AAMI/ANSI ES60601-1 and IEC 60601-2-37. Software and hardware verification, integration testing, performance validation, and safety testing were completed. Clinical studies were not required to support substantial equivalence. The device was found to be as safe and effective as the predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/31/2020
5 months - 2
FDA Approval
9/9/2020
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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