Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and Primary Care DiagnosticsThe Vivid S60N and Vivid S70N are advanced general-purpose ultrasound imaging systems by GE Healthcare, specialized for cardiac imaging but also supporting a broad range of diagnostic ultrasound applications across the human body. These systems facilitate ultrasound imaging, measurement, display, and analysis to assist physicians in clinical environments such as hospitals and private offices, enhancing diagnostic accuracy and workflow efficiency through digital acquisition, processing, and semi-automated AI-based measurement features.
Intended Use
Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. 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, in hospital and private office environments. Supports clinical applications including fetal/obstetrics, abdominal, pediatric, small organ, neonatal cephalic, cardiac, peripheral vascular, musculoskeletal, urology, and interventional guidance.
Technology
The system consists of a mobile console with height-adjustable control panel, color LCD touch panel, LCD display monitor, and optional image storage and printing devices. It uses a variety of electronic array transducers (linear, curved, sector/phased array, matrix, or dual array). It includes electronics for transmitting/receiving ultrasound data, signal processing, software computing, and interfaces via LAN and wireless connections.
Performance
Performance validation included biological evaluation, ultrasonic field characterization, risk management, non-clinical safety and effectiveness testing per applicable standards, and quality assurance measures such as design reviews, module and system verification, and safety testing. Clinical studies were not required to support substantial equivalence for this premarket submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/28/2020
4 months - 2
FDA Approval
7/16/2020
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