The Vivid iq is a high-performance compact diagnostic ultrasound system designed for cardiovascular and shared service imaging. It assists healthcare professionals in ultrasound imaging, measurement, display, and analysis of human body and fluid, across a wide range of clinical applications including fetal, cardiac, abdominal, musculoskeletal, and vascular imaging. It incorporates advanced ultrasound modes such as Doppler, color Doppler, harmonic imaging, and real-time 3D imaging, supporting various transducers and enabling flexible clinical use in hospital and office environments.
Intended Use
The Vivid iq is a high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Technology
The system is a general-purpose diagnostic ultrasound device consisting of electronics for transmit and receive of ultrasound data, signal processing, software computing, image storage, printing, and network access. It supports a variety of electronic array transducers including linear, curved, sector/phased array, matrix array, dual array, CW transducers, and real-time 3D transducers, enabling multiple imaging modes including B, M, Doppler, Color Doppler, Power Doppler, Harmonic Imaging and Real-Time 3D (4D). The device includes AI-based automated ROI algorithms for cardiac function analysis.
Performance
The device underwent extensive non-clinical testing including acoustic output, biocompatibility, cleaning and disinfection, and electrical, thermal, electromagnetic, and mechanical safety. It complies with applicable medical safety standards. The AI algorithms Easy Auto EF and Easy AFI LV were tested on 135 images from 45 patient exams collected across multiple countries, achieving average dice scores of 91-92% for segmentation tasks, using rigorously annotated data from certified cardiologists and independent expert panel review. The device did not require clinical trials to support equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/20/2022
2 months - 2
FDA Approval
7/18/2022
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