6440 MyLabX90
Esaote S.p.A.The 6440 MyLabX90 by Esaote is an advanced multifunctional ultrasound scanner that supports real-time imaging and analysis during diagnostic ultrasound procedures. It integrates AI features like automated endocardial border detection for cardiac function assessment and lesion contouring for breast exams, helping clinicians improve diagnostic accuracy and efficiency across multiple body regions.
Intended Use
The multifunctional ultrasound scanner MyLabX90 is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes across multiple body regions including cardiac, vascular, abdominal, breast, musculoskeletal, neonatal, pediatric, small organs, thyroid, urological, and women health. The Virtual Navigator option supports ultrasound examination by providing additional image information from second modalities such as CT, MR, US, PET, XA, and NM, enhancing assessment of real-time ultrasound images.
Technology
The device is based on a movable mainframe platform supporting multiple advanced ultrasound modes including B-Mode, M-Mode, Doppler, Color Flow Mapping, 3D/4D imaging, and specific AI-powered features such as AutoEF for cardiac LV volume and ejection fraction measurement, eDetect for breast lesion contouring, and XStrain for cardiac deformation analysis. It supports multiple probe types including phased array, convex, linear, Doppler, and volumetric probes. The device integrates Virtual Navigator software for image fusion with CT, MR, US, PET, XA, and NM modalities.
Performance
Performance testing included clinical validation of AI algorithms with independent datasets. The eDetect breast lesion contouring AI demonstrated over 80-90% success rates in Bi-Rads feature parameters and achieved the acceptance threshold for lesion contour overlap (IOU>0.85). The AutoEF cardiac AI showed Dice coefficients of 0.95±0.02 against expert annotations in cardiac LV border segmentation across multiple views. Safety and regulatory compliance testing include IEC standards for electrical, acoustic, and mechanical safety. No additional clinical trials were performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/23/2023
10 months - 2
FDA Approval
11/29/2023
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