LOGIQ Totus is a comprehensive diagnostic ultrasound system designed for use by trained healthcare professionals. It offers imaging, measurement, display, and analysis for a wide range of clinical applications, including obstetrics, abdominal, cardiac, vascular, and musculoskeletal imaging. The system supports multiple ultrasonic imaging modes and integrates AI-enabled features such as auto preset selection and auto abdominal color assistant to improve efficiency and accuracy in clinical settings.
Intended Use
A general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Technology
The LOGIQ Totus consists of a mobile console with a user interface including computer keyboard, specialized controls, a 14-inch LCD touch screen and a 23.8-inch HD image display. It supports multiple modes of operation such as B, M, PW Doppler, CW Doppler, Color Doppler, Harmonic Imaging, 3D/4D Imaging, Elastography, Shear Wave Elastography, Attenuation Imaging, Contrast Enhanced Imaging, and combined modes. AI features include auto preset selection and auto abdominal color assistant to assist imaging workflows.
Performance
Performance testing included software validation with AI testing demonstrating model success rates of 80% or higher for various view suggestions such as Abdomen, Air, Breast, Carotid, and Abdominal Color Assistant. Non-clinical testing confirmed compliance with electrical, mechanical, electromagnetic and acoustic safety standards as well as biocompatibility. No clinical studies were required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/8/2023
4 months - 2
FDA Approval
12/7/2023
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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