The Vivid iq is a high-performance compact diagnostic ultrasound system made by GE Medical Systems Ultrasound. It supports a wide range of clinical applications including cardiovascular, abdominal, fetal, musculoskeletal, and more. The system enables automatic AI-based cardiac measurements and spectrum recognition to assist clinicians in analysis and diagnosis. It is intended for use by trained healthcare professionals in hospitals and private medical offices.
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. Clinical applications include fetal/obstetrics, abdominal (GYN, urology), pediatric, small organ (breast, testes, thyroid), neonatal cephalic, adult cephalic, cardiac (adult and pediatric), peripheral vascular, musculoskeletal conventional and superficial, transcranial, transrectal, transvaginal, transesophageal, interventional guidance (including biopsy), intraoperative (vascular), intracardiac and intraluminal.
Technology
The Vivid iq is an ultrasound imaging & analysis system with a compact console, color LCD touch panel, and supports multiple linear, sector, convex and phased array transducers. It supports various modes including B, M, PW Doppler, CW Doppler, Color Doppler, Harmonic Imaging, Real-Time 3D (4D), and combined modes. It features AI Auto Measure for cardiac 2D measurements and spectrum recognition, as well as tools for left and right ventricular strain analysis and other quantitative assessments.
Performance
The Vivid iq has undergone testing for acoustic output, biocompatibility, cleaning and disinfection, and electrical, thermal and mechanical safety, complying with applicable medical device safety standards. It also complies with standards including AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, IEC 62359, ISO 14971, and NEMA DICOM. Non-clinical tests and software verification and validation have been performed. Clinical studies were not required for this submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/18/2020
5 months - 2
FDA Approval
9/9/2020
Other devices from GE Medical Systems Ultrasound and
- Vivid E80, Vivid E90, Vivid E952022 • 510K
- Vivid E80/ Vivid E90/ Vivid E952020 • 510K
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