The Vivid iq is a high-performance compact diagnostic ultrasound system designed primarily for cardiovascular and shared services imaging, but also applicable to various clinical areas such as fetal, abdominal, pediatric, musculoskeletal, and vascular imaging. It supports multiple ultrasound modes including Doppler and real-time 3D imaging. The system aids healthcare professionals by providing advanced ultrasound imaging and analysis capabilities for better diagnosis and patient care.
Intended Use
The Vivid iq is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid.
Technology
The Vivid iq system is a general-purpose, Track 3, diagnostic ultrasound device, consisting of a compact console with multiple transducer options (linear, curved, sector/phased, matrix, dual array), electronic array transducers, and software for ultrasound signal processing, image storage, and network connectivity. It supports various imaging modes (B, M, PW Doppler, CW Doppler, Color Doppler, etc.) and real-time 3D imaging, maintaining the same fundamental scientific technology as its predicate device.
Performance
The device was tested for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic and mechanical safety, and complies with multiple voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-2-37, ISO 10993-1, ISO 14971, and DICOM standards. Clinical studies were not required to support substantial equivalence. Performance testing included risk analysis, design reviews, integration, verification, validation, and safety testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/22/2024
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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