LOGIQ E10s, LOGIQ Fortis
GE Medical Systems Ultrasound and Primary Care Diagnostic,The LOGIQ E10s and LOGIQ Fortis are advanced general-purpose diagnostic ultrasound systems designed for use by trained healthcare professionals. They provide high-resolution ultrasound imaging and measurements across a wide range of clinical applications, including obstetrics, abdominal, cardiac, vascular, musculoskeletal, and intraoperative imaging. The systems incorporate various imaging modes such as Doppler, elastography, 3D/4D imaging, and AI-powered assistant features to enhance workflow and diagnostic accuracy, thereby assisting clinicians in evaluating and analyzing human body structures and fluids effectively.
Intended Use
General-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid across various clinical applications including fetal/obstetrics, abdominal, pediatric, small organ, cardiac, peripheral vascular, musculoskeletal, urology, transrectal, transvaginal, transesophageal, and intraoperative.
Technology
The device consists of mobile ultrasound consoles with digital acquisition, processing, and display capabilities. It includes specialized controls, high-resolution displays, and supports multiple imaging modes such as Doppler, harmonic imaging, 3D/4D imaging, elastography, and AI-powered assistant features for preset, color assistant, and renal measurement. It operates at acoustic power levels below FDA limits and complies with medical electrical and safety standards.
Performance
Performance testing included AI validation for the Auto Renal Measure Assistant, Auto Abdominal Color Assistant, and Auto Preset Assistant using datasets from multiple patients at different sites with independent training and validation datasets. The tests demonstrated high measurement accuracy and model success rates exceeding 80%. The device was tested for electrical, acoustic output, biocompatibility, and safety compliance with relevant standards. Clinical studies were not required due to substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/5/2023
4 months - 2
FDA Approval
11/7/2023
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