Vivid T9/Vivid T8
GE Medical Systems Ultrasound and Primary Care DiagnosticsThe Vivid T9/Vivid T8 is a diagnostic ultrasound system primarily intended for cardiac imaging but also supports vascular and general radiology applications. It provides digital acquisition, processing, measurement, display, and analysis of ultrasound images using various transducers and imaging modes. The system supports a range of clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, helping healthcare professionals in hospitals and clinics obtain real-time detailed images for diagnostic purposes.
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 hospital environments including echo lab, other hospital settings, operating room, Cath lab, and private medical offices.
Technology
A mobile console diagnostic ultrasound system with control panel, LCD touch panel and monitor, supporting a variety of electronic array transducers operating in linear, curved, sector/phased, matrix, and dual arrays including CW transducers. It includes imaging modes such as B, M, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Harmonic Imaging, and coded pulse combined modes. The system supports digital acquisition, processing, analysis, and display with real-time image processing (Clarity +) to reduce noise and sharpen structures. It has network connectivity via LAN and optional wireless adapter.
Performance
The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and safety (thermal, electrical, electromagnetic, mechanical), confirming conformance with applicable medical device safety standards and voluntary standards such as IEC 60601 series, ISO 10993-1 for biocompatibility, and ISO 14971 for risk management. No clinical studies were required to support substantial equivalence. Quality assurance measures included design reviews, unit and integration testing, and verification and validation of performance and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2024
2 months - 2
FDA Approval
2/11/2025
Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics
- Venue; Venue Go; Venue Fit; Venue Sprint2025 • 510K
- EchoPAC Software Only / EchoPAC Plug-in2025 • 510K
- Vivid Pioneer2025 • 510K
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