Vivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and Primary Care Diagnostics,The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also support other applications such as fetal, abdominal, pediatric, vascular, and musculoskeletal imaging. These systems use ultrasound technology to produce detailed real-time images, including 3D and 4D imaging, helping clinicians diagnose and monitor various conditions effectively. The devices also feature enhanced workflow tools, advanced imaging options, and support comprehensive networking and data sharing capabilities, improving the efficiency and accuracy of ultrasound examinations.
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 physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Technology
The Vivid E80 / Vivid E90 / Vivid E95 operate using ultrasonic pulsed Doppler imaging and pulsed echo imaging technologies, supporting 2D, 3D, and 4D real-time imaging. The system uses electronic array transducers in linear, curved, sector/phased array, or matrix array format. They run under Windows 10 Embedded OS and include advanced software features such as CT Fusion, automated annotation, and streaming capabilities for remote review, among others.
Performance
The systems have undergone extensive non-clinical testing including acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, mechanical safety, and software validation. They comply with relevant standards including IEC60601, ISO10993, and DICOM. Clinical studies were not required to demonstrate substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/26/2018
4 months - 2
FDA Approval
10/25/2018
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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