Versana Premier
GE Medical Systems Ultrasound and Primary Care Diagnostics,Versana Premier is a general purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It supports multiple clinical applications such as fetal, abdominal, gynecological, cardiac, vascular, musculoskeletal, and more. It includes various advanced imaging modes and features AI-based enhancements like Whizz Label to assist clinicians in acquiring and interpreting ultrasound images efficiently and accurately. The system is intended for hospitals and medical clinics to aid in the diagnosis and assessment of medical conditions.
Intended Use
The Versana Premier is 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 Versana Premier is a mobile console diagnostic ultrasound system including transducers for various access types and employs the same fundamental scientific technology as its predicate device. It supports multiple imaging modes and advanced features such as AI-based Whizz Label, color flow optimization, and enhanced imaging modes for diagnostic applications.
Performance
The device underwent acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety testing. It complies with relevant medical device safety standards and passed quality assurance reviews, unit and integration testing, and verification of performance and safety. No clinical studies were required to support substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/12/2021
7 months - 2
FDA Approval
9/10/2021
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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