Versana Premier; Versana Premier Lotus; LOGIQ F
GE Medical Systems Ultrasound and Primary Care DiagnosticsThe Versana Premier, Versana Premier Lotus, and LOGIQ F are diagnostic ultrasound systems intended for use by trained healthcare professionals. They provide ultrasound imaging, measurement, display, and analysis for various body regions and clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and more, helping clinicians visualize and diagnose conditions through advanced ultrasound technology.
Intended Use
The Versana Premier/Versana Premier Lotus/LOGIQ F 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. Clinical applications include fetal/obstetrics, abdominal, gynecology, urology, pediatric, small parts (breast, testes, thyroid), cardiac adult and pediatric, vascular/peripheral vascular, musculoskeletal conventional and superficial, thoracic/pleural, transcranial, transrectal, transvaginal, transesophageal, and interventional guidance (tissue biopsy, fluid drainage, vascular and non-vascular access). Modes include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D imaging modes and combined modes.
Technology
The system is a mobile console that includes an operator control panel, display monitor, and multiple types of transducers (convex, linear, sector, Bi-plane, mechanical 4D) with access types including trans-body surface, transrectal, transvaginal, transcranial, and transesophageal. It provides digital acquisition, processing, and display capability with multiple ultrasound modes combining Doppler and harmonic imaging technologies.
Performance
The device complies with recognized medical electrical equipment safety standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37 etc.), biocompatibility standards, and digital imaging standards (DICOM). It has undergone risk analysis, design reviews, unit/module verification, integration and performance testing, as well as safety testing. Clinical studies were not required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/9/2024
2 months - 2
FDA Approval
10/2/2024
Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics
- Vivid Pioneer2025 • 510K
- Voluson Signature 20, Voluson Signature 182024 • 510K
- LOGIQ Totus2023 • 510K
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