Vivid E80/ Vivid E90/ Vivid E95
GE Medical Systems Ultrasound andThe Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems specialized for cardiac imaging but also capable of vascular and general radiology applications. Featuring AI-driven tools for cardiac image analysis, these systems enable clinicians to perform automated measurements and enhanced visualization to improve efficiency and reduce variability. They support various clinical settings including hospitals and private offices with a range of imaging modes and transducers.
Intended Use
Vivid E80 / Vivid E90 / Vivid E95 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.
Technology
A diagnostic ultrasound system with electronic array transducers (linear, curved, sector/phased array, matrix array, dual array), including CW and real-time 3D transducers. It provides digital acquisition, signal processing, software computing, image storage, printing, and network connectivity via LAN or wireless. AI features include automated 2D cardiac measurements, spectrum recognition for Doppler analysis, and advanced 3D/4D imaging modes.
Performance
Evaluated for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, mechanical safety, complying with standards such as AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, IEC 62359, ISO 14971, and NEMA DICOM standards. Testing includes risk analysis, requirements and design reviews, unit/module and system verification, performance validation, and safety verification. No clinical studies were required for this submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/23/2020
4 months - 2
FDA Approval
7/23/2020
Other devices from GE Medical Systems Ultrasound and
- Vivid E80, Vivid E90, Vivid E952022 • 510K
- Vivid iq2020 • 510K
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