6440 MyLabX90

by Esaote S.p.A.  · Based in Italy → — Experience Intelligent Imaging.
Cardiology Obstetrics & Gynecology Radiology

Regulatory Status Disclosed

Overview

The Esaote MyLab™X90 is a premium ultrasound platform designed to deliver outstanding image quality and advanced clinical solutions, bridging clinical information with an A.I.-driven workflow. It represents Esaote’s first Intelligent Imaging ultrasound device. The system incorporates ClearWave Architecture, combining XPower Beamforming and XSmart Postprocessing technologies for a new standard in image quality. It features an exclusive eLed monitor developed by Barco, offering brilliant colors, infinite contrast, and high stability. The MyLab™X90 is engineered to optimize workflows and support advanced, interconnected healthcare systems through its native AI-based application management. It offers advanced ergonomics, including a 15.6” touchscreen and integrated lighting, to enhance the operator experience and diagnostic confidence.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-driven workflow solutions (Augmented Insightu2122)
  • UroFusion for AI-driven prostate navigation and automatic segmentation
  • AI-powered automatic segmentation of skin profile for abdomen registration
  • Extensive AI-driven automatic measurements (e.g., AutoEF, AutoCM)
  • AutoOB for AI-integrated fetal biometric measurements and smart Auto scanplane
  • QAI (Quantification Attenuation Imaging) for hepatic steatosis evaluation
  • AI-driven AutoSync for 3D camera registration
  • eDetect for breast lesion contouring
  • XStrain for cardiac deformation analysis
  • ClearWave Architecture for superior image quality

Use Cases

  • Diagnostic ultrasound procedures across multiple body regions (cardiac, vascular, abdominal, breast, musculoskeletal, neonatal, pediatric, small organs, thyroid, urological, women's health)
  • Prostate navigation and biopsy support with ultrasound and MRI fusion
  • Fetal biometric measurements and obstetric workflow optimization
  • Assessment of diffuse liver disease and hepatic steatosis
  • Cardiac function assessment and deformation analysis
  • Image fusion with other modalities (CT, MR, PET, XA, NM) for enhanced assessment

What Physicians Need to Know

ECG/EKG Analysis Capability
The MyLabX90 integrates real-time ECG for cardiac monitoring during ultrasound examinations, with capabilities for detecting electrode detachment and cardiac stimulator activity.
Echocardiography AI Features
Features Esaote's 'Augmented Insightu2122' with AI-driven tools for cardiac strain evaluation and streamlined workflows. It includes 'zero-click tools' such as AutoEF for automatic AI-driven left ventricle contouring and ejection fraction assessment, XStrainu2122 for zero-click detection of endocardial border profiles and strain assessment of the left and right ventricles, and HyperDoppler for advanced visualization of intracardiac vortices and flow dynamics, aiding in the detection of subtle dysfunction, particularly in heart failure cases. AutoCM also facilitates standard left ventricle measurements.
Cardiac CT/MRI Analysis
While primarily an ultrasound system, the MyLabX90 supports a multimodality approach and fusion imaging via its Virtual Navigator software, integrating additional image information from CT, MR, US, PET, XA, and NM to assist in percutaneous procedures and comprehensive anatomical assessment.
Arrhythmia Detection Accuracy
Includes an alarm system for monitored parameters and arrhythmia, along with detection and sound signaling of cardiac stimulator activity, indicating basic arrhythmia monitoring capabilities.
Heart Failure Risk Prediction
Although not explicitly termed 'risk prediction,' the advanced cardiac function analysis tools like AutoEF, XStrainu2122, and HyperDoppler provide detailed insights into LV, RV, and LA strain, ejection fraction, and intracardiac flow dynamics, which are crucial for assessing cardiac health and identifying indicators relevant to heart failure, with HyperDoppler specifically supporting earlier detection of subtle dysfunction in heart failure cases.
Coronary Artery Assessment
The system includes QIMT (Quality Intima Media Thickness) and QAS (Quality Arterial Stiffness) as zero-click tools for cardiovascular function quantification, which are relevant for vascular health assessment.
Cardiac Monitoring Integration
Offers integrated patient monitoring with a large 7u201d TFT color display for real-time ECG, SpO2, ETCO2, NIBP, and IBP during examinations.
AHA/ACC Guideline Alignment
Esaote's cardiac ultrasound systems, including the MyLabX90, provide a full range of standard measurements for structural, functional, and hemodynamic evaluations, aligning with ASE/EACVI guidelines.
Real-Time Alert Capability
Features an alarm system for monitored parameters and arrhythmia, providing real-time alerts for critical changes during examinations.
Physician Tip

Leverage the MyLabX90's Augmented Insightu2122 suite for rapid and accurate AI-driven quantification of left and right ventricular function and strain (AutoEF, XStrainu2122), crucial for early detection of cardiomyopathies and cardiotoxicity. Utilize HyperDoppler for advanced insights into complex intracardiac flow dynamics, aiding in the detection of subtle dysfunction, particularly in heart failure. For complex cases or interventional procedures, the Virtual Navigator's fusion imaging capability with CT/MRI data can provide a comprehensive anatomical overview, enhancing diagnostic confidence and procedural guidance. The integrated patient monitoring and robust connectivity features streamline workflow and facilitate data sharing for multidisciplinary collaboration.

The MyLabX90 offers extensive integration capabilities, supporting a multimodality approach through its Virtual Navigator software for fusion imaging with CT, MR, US, PET, XA, and NM data. It provides full DICOM connectivity, including Query/Retrieve (Q/R), and integrates with Esaote's MyLabu2122Desk, MyLabRemote, and eStreaming solutions for efficient medical data management, remote collaboration, and live streaming. The system is designed with robust security measures, including Windowsu00ae 10, to ensure GDPR compliance and secure patient data transfer, and supports wireless and wired network communication, including HL7 standard for examination orders and results.

Details

Category Cardiology AI, OB/GYN AI, Radiology & Imaging AI
Pricing Unknown
DeploymentOn-premise (physical ultrasound system)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The 6440 MyLabX90 received FDA 510(k) clearance (K230179) on November 29, 2023, as an advanced multifunctional ultrasound scanner. It supports real-time imaging and analysis during diagnostic ultrasound procedures, integrating AI features for cardiac function assessment and breast lesion contouring.

Integrations
EHR Not specified
Specialties Cardiology, Obstetrics & Gynecology, Radiology

What the Web Says

The Esaote 6440 MyLabX90 is a premium ultrasound system that incorporates artificial intelligence (AI) to enhance workflow, image quality, and diagnostic confidence. It features advanced ergonomics, a renewed XCrystal probe family, and a dual-layer eLed monitor for superior image display. The system is designed to be versatile for various clinical applications, including cardiovascular, obstetrics, and general imaging, and has received FDA clearance.

Overall: Positive

Strengths

  • AI-powered workflow optimization for increased speed and accuracy.
  • Exceptional image quality with high contrast resolution due to XCrystal probes and eLed monitor.
  • Advanced ergonomics and user-friendly interface.
  • Comprehensive clinical applications, including specialized tools for cardiac and obstetric examinations.
  • Versatile probes adaptable for a wide range of patient sizes and types (e.g., in veterinary medicine).
  • FDA cleared with new capabilities like AutoEF and eDetect for breast lesion contouring.

Limitations

  • No specific physician or tech reviewer reviews were found outside of promotional materials.
  • No reviews available on G2, Capterra, or Reddit.
  • No clinical tests were performed for the upgraded 6440 MyLabX90 system, only substantial equivalence was determined.

Based on reviews from: Esaote (via vertexaisearch.cloud.google.com), BioTech Services (Esaote Distributor), FDA.gov (via Innolitics and accessdata.fda.gov)

Last updated: 2026-07-17

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Press & Coverage

GlobalData
Esaote Receives FDA 510(k) Clearance for 6440 MyLabX90
Esaote received FDA 510(k) clearance for its 6440 MyLabX90 ultrasound system on December 20, 2023. This clearance is part of broader industry activity in the ultrasound systems pipeline, with many companies receiving regulatory approvals around the same time.
2023-12
FDA
510(k) Premarket Notification - K230179
The FDA's 510(k) Premarket Notification K230179 details the clearance of Esaote's 6440 MyLabX90, an ultrasonic pulsed Doppler imaging system, on November 29, 2023. The document lists Esaote S.p.A. as the applicant and provides regulatory classification and product codes.
2023-11
FDA-cleared directory
Ultrasound radiology AI tools | FDA-cleared directory
The 6440 MyLabX90 by Esaote S.p.A. is listed in the FDA-cleared directory for ultrasound radiology AI tools, with a decision date of November 29, 2023. It is categorized for image analysis/processing within ultrasound workflow.
2023-11
accessdata.fda.gov
Total Product Life Cycle (TPLC) - 6440 MyLabX90
The FDA's Total Product Life Cycle (TPLC) database includes the 6440 MyLabX90, indicating its substantial equivalence to other Esaote ultrasound systems like the 6430 MyLabX75. This entry provides a comprehensive overview of the device's regulatory journey.
2026-07
Innolitics
6600 Ultrasound System (MyLabA70) (K243253) u2014 FDA 510(k)
The 6440 MyLabX90 is cited as a predicate device for Esaote's newer 6600 Ultrasound System (MyLabA70) in its FDA 510(k) submission (K243253). This indicates the MyLabX90's established regulatory standing and its role in the development of subsequent ultrasound technologies.
2025-06

Videos

Product demos, reviews, and walkthroughs for 6440 MyLabX90.

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Frequently Asked Questions

The MyLabX90 integrates AI features like AutoEF for automated cardiac function assessment, eDetect for breast lesion contouring, and UroFusion for prostate navigation, which aim to increase speed and accuracy in measurements and analysis. These AI-driven tools streamline repetitive gestures and complex procedures, improving diagnostic confidence and overall workflow efficiency across various clinical applications.
The 6440 MyLabX90 has received FDA clearance (K230179) and complies with the Medical Device Directive (MDD) 93/42/EEC, classifying it as a Class IIa device. It also provides a high level of protection against external threats and ensures patient data safety in compliance with GDPR, facilitating secure data transfer.
While the MyLabX90's AI tools, such as AutoEF and eDetect, have demonstrated high success rates in performance testing, they are designed to assist and simplify workflows, not replace clinical judgment. Physician oversight remains crucial for confirming AI-generated contours, measurements, and analyses, as the AI acts as an augmented insight tool.
The MyLabX90 is a premium, cart-based ultrasound system known for its advanced AI-driven workflow enhancements, XCrystal transducer technology, and ClearWave architecture for superior image quality. While other systems like Sonoscape, Fujifilm Sonosite, GE LOGIQ, and Toshiba offer various advanced features, the MyLabX90 focuses on a comprehensive shared-service solution with integrated AI for cardiovascular and women's health applications.
The MyLabX90 is described as a 'premium' ultrasound system, and pricing information is generally available upon request from distributors. While specific pricing models or subscription options for its AI features are not detailed in the provided information, it's common for advanced medical equipment to offer various configurations and potentially software-as-a-service models for AI functionalities.
The MyLabX90 is designed with extreme security, leveraging Windowsu00ae 10 to provide a high level of protection against external threats. It ensures data transfer and patient data safety in compliance with GDPR, facilitating secure multimodality approaches and live streaming.
While specific details on training programs are not extensively outlined, distributors like Imotek offer full system training free of charge upon delivery of the MyLabX90VET, suggesting similar support for the human MyLabX90. The system's intuitive touchscreen interface and AI-driven workflow simplifications are designed to enhance usability and operator experience.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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