LOGIQ E10 is a general-purpose diagnostic ultrasound imaging system designed for use by qualified physicians. It supports multiple ultrasound modes such as B-mode, Doppler imaging, harmonic imaging, elastography, and 3D/4D imaging, providing digital image acquisition and processing. The system includes AI-powered features like Auto Renal Measure Assistant and Auto Abdominal Color Assistant to assist clinicians by automating measurements and suggesting anatomical views, thus improving workflow efficiency and diagnostic accuracy.
Intended Use
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
Technology
The LOGIQ E10 is a full featured diagnostic ultrasound system including a mobile console with a keyboard, specialized controls, color touch screen, and LED monitor. It supports multiple ultrasound modes such as B, M, PW Doppler, CW Doppler, Color Doppler, Harmonic Imaging, Elastography, Shear Wave Elastography, Attenuation Imaging, and 3D/4D imaging. The system includes AI features like Auto Preset Assistant, Auto Color Assistant, Auto Renal Measure Assistant, and more.
Performance
Performance testing included AI validation of automated measurement and anatomical view suggestion algorithms. For the Auto Renal Measure Assistant, testing on 30 diverse patients showed measurement accuracy above 80% with strong agreement to ground truth from sonographers and nephrologists. For the Auto Abdominal Color Assistant and Auto Preset Assistant, success rates in anatomical view identification were above 80%, tested on over 50 and 110 patients respectively. Non-clinical testing confirmed safety and compliance with electrical, mechanical, thermal, and biocompatibility standards. No clinical studies were required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/3/2023
4 months - 2
FDA Approval
11/7/2023
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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