Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and Primary Care Diagnostics,The Vivid S60N and Vivid S70N are advanced, general-purpose ultrasound systems specialized for cardiac imaging, but also supporting multiple other clinical applications such as abdominal, vascular, and musculoskeletal imaging. They provide digital ultrasound image acquisition, processing, analysis, and display with various transducer options and imaging modes. The systems include AI-powered features like Easy Auto EF and Easy AFI LV for automated cardiac function assessment to assist clinicians in evaluating heart health efficiently.
Intended Use
Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support multiple clinical applications including cardiac (adult and pediatric) and others.
Technology
The system includes a mobile console with adjustable control panel and color monitors, supports multiple array transducers including 3D real-time, provides ultrasound transmit/receive electronics, signal processing, software computing, image storage, network access, and diverse operational modes such as B-mode, Doppler, Color Doppler, Harmonic imaging, and combined modes. AI features include Easy Auto EF and Easy AFI LV for automatic delineation and functional analysis of the left ventricle using AI-based ROI algorithms.
Performance
The Vivid S60N/S70N comply with recognized medical device safety standards and underwent extensive non-clinical tests for acoustic output, biocompatibility, electrical and mechanical safety, and EMI. AI algorithm performance for Easy Auto EF and Easy AFI LV showed accuracy above 91-92% across diverse datasets. Clinical datasets were tested with expert cardiologist annotations for AI validation. No new clinical studies were needed for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/3/2022
4 months - 2
FDA Approval
7/15/2022
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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