TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System

Cardiology Critical Care Emergency Medicine

Regulatory Status Disclosed

Overview

Important Note: The provided details (Tool name, Company, and FDA clearance number K212265) refer to a series of Diagnostic Ultrasound Systems, specifically the Mindray TEX20 and TEX10 series, not an AI tool for a physician directory as initially requested. This JSON response provides comprehensive information about the Mindray TEX series Diagnostic Ultrasound Systems.

The Mindray TEX20/TEX10 series Diagnostic Ultrasound Systems are advanced point-of-care (POC) ultrasound solutions designed to enhance diagnostic accuracy and workflow efficiency in demanding clinical environments such as critical care, emergency medicine, and anesthesia. These systems feature Mindray’s innovative ZONE Sonography® Technology (ZST+) for exceptional image clarity and uniformity, along with a suite of ‘Smart Tools’ for quick and precise assessments. Key design elements include a rotatable 23.8-inch full-touch HD screen, multiple transducer connectors, and advanced wireless solutions like wireless transducers and voice control (iVocal Plus) to optimize user experience and flexibility. The groundbreaking X-Link solution integrates ultrasound imaging with other physiological information, such as ECG signals, onto a single display, providing clinicians with a holistic view of the patient’s condition for improved decision-making.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • ZONE Sonographyu00ae Technology (ZST+) for enhanced image quality
  • X-Link solution for integrated ultrasound and physiological information display (e.g., ECG)
  • 23.8-inch rotatable full-touch HD screen for flexible viewing
  • Wireless voice control (iVocal Plus) for hands-free operation
  • Smart Tools for automated measurements and guidance (e.g., AutoEF Plus, Smart VTI, Smart IVC, Smart B-line, Smart Nerve)
  • 4 active transducer connectors for diverse applications
  • Wireless transducers for increased mobility and flexibility
  • Sealed interface for fluid resistance and easy disinfection
  • Fast workflows and ease of use and maintenance
  • Data transfer via DICOM standard, network pad, or USB

Use Cases

  • critical-care-imaging
  • emergency-medicine-diagnostics
  • anesthesia-guidance
  • cardiac-assessment
  • fluid-management
  • nerve-block-guidance
  • trauma-assessment

What Physicians Need to Know

ECG/EKG Analysis Capability
The TEX20 series integrates ECG signals with ultrasound imaging via X-Link technology and Physio-View, allowing real-time overlay of ECG waveforms for correlated cardiac and respiratory function assessment. Mindray's advanced ECG algorithms, which can be integrated, offer robust anti-interference and accurate arrhythmia detection, reducing false alarms.
Echocardiography AI Features
Features include Smart Echovue for automatic cardiac view recognition and scanning guidance, AutoEF Plus for real-time 2D echo analysis, endocardium tracing, and automated EDV/ESV/EF calculation by the Simpson method. Auto DFR automatically calculates E/A and E/E' for diastolic function evaluation. Smart TTQA provides automated myocardial motion analysis and displays mechanical changes of left ventricular segments. Smart VTI Plus offers automatic measurement of cardiac output, stroke volume, and velocity time integral.
Arrhythmia Detection Accuracy
The system's integration with Mindray's advanced ECG monitoring capabilities, which include a four-lead ECG analysis algorithm, provides strong anti-interference and accurate detection of arrhythmias, including Atrial Fibrillation (AF), even in noisy environments, aiming to reduce false alarms.
Heart Failure Risk Prediction
The TEX20 series supports hemodynamic assessment and fluid management with AI-driven tools such as Smart VTI Plus, Smart IVC (Inferior Vena Cava), and Smart B-line, which are critical for managing patients with heart failure and assessing fluid status. Smart TTQA's myocardial motion evaluation also contributes to assessing cardiac function.
Cardiac Monitoring Integration
X-Link technology consolidates ultrasound images, ECG signals, and other physiological data onto a single display for a holistic patient view and real-time monitoring. Physio-View overlays ECG and physiological waveforms directly onto ultrasound images. The system also supports connectivity to Electronic Patient Record (EPR) systems via Mindray eGateway and can integrate data to a central station for review.
AHA/ACC Guideline Alignment
The X-Pilot suite is designed based on professional society guidelines for point-of-care ultrasound, integrating multi-organ data to support rapid clinical decisions. It assists in identifying shock types (e.g., RUSH, FALLS, GDE protocols) and evaluating acute respiratory distress (e.g., BLUE protocol), aligning with established clinical standards.
Real-Time Alert Capability
The system's integrated display of physiological data and ultrasound images facilitates immediate decision-making. Mindray's ECG algorithms, when integrated, are designed to reduce false alarms and missed critical alerts through intelligent alarm management, enhancing patient safety.
Physician Tip

Leverage the TEX20 series' AI-driven 'Smart Tools' like AutoEF Plus, Auto DFR, and Smart TTQA for rapid, standardized, and accurate cardiac function assessments at the point of care, especially in critical and emergency settings. Utilize the X-Link and Physio-View features to integrate real-time ECG and other physiological data with ultrasound images for a comprehensive patient overview and improved diagnostic confidence. The system's guideline-aligned X-Pilot suite can streamline shock and respiratory distress evaluations, even for non-cardiologists. Embrace the wireless capabilities and voice control for enhanced workflow efficiency and infection control.

The Mindray TEX20 series offers seamless integration of physiological data, including ECG, with ultrasound imaging through its proprietary X-Link technology. It supports connectivity to leading Electronic Patient Record (EPR) systems via Mindray eGateway for efficient data transfer and reporting. The U-View application allows for integration of ultrasound images and physiological information to a central monitoring station, facilitating multidisciplinary treatment and advanced clinical research.

Details

Category Cardiology AI, OB/GYN AI, Radiology & Imaging AI
Pricing Unknown
DeploymentOn-premise
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System and TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System received 510(k) premarket notification clearance (K212265) from the FDA on November 16, 2021. These devices are intended for various diagnostic imaging applications in adults, pregnant women, pediatric patients, and neonates, covering areas such as ophthalmic, fetal, abdominal, cardiac, musculoskeletal, and more.

Integrations
EHR Not specified
Specialties Cardiology, Critical Care, Emergency Medicine

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Press & Coverage

Mindray
Mindray Reimagines Point of Care Systems with Launch of New TEX20 Diagnostic Ultrasound Series at Euroanaesthesia 2022
Mindray launched its TEX20 Series Point of Care ultrasound system at Euroanaesthesia 2022, aiming to redefine critical care and emergency medicine with a patient-centered information solution, extreme image clarity, and smart tools. The system features X-Link technology, which synchronizes physiological information with ultrasound images on a single screen for a holistic patient view.
2022-06
Medicare Singapore
Mindray Launches TEX20 Diagnostic Ultrasound Series at Euroanaesthesia, Redefining Point-of-Care Imaging - Medicare Singapore
The Mindray TEX20 Series, a next-generation point-of-care ultrasound (POCUS) system, was unveiled at Euroanaesthesia 2022 to transform bedside diagnostics in critical care, anesthesiology, perioperative care, and emergency medicine. It features X-Link technology to consolidate ultrasound imaging and physiological data on a single display, enhancing clinical decision-making.
2025-02
Mindray
TEX20 - Mindray
The Mindray TEX20 Diagnostic Ultrasound System is designed for point-of-care, featuring the ZONE Sonographyu00ae Technology (ZST+) platform for exceptional image quality and X-Link for integrating physiological data with ultrasound images. It includes a 23.8u2033 rotatable full-touch HD screen, four active transducer connectors, and smart tools like iVocal Plus and AutoEF Plus.
unknown
Mindray
Keeping Pace with Emergency: TEX20 POC Ultrasound Ready at Every Turn - Mindray
This article highlights the Mindray TEX20 Series point-of-care ultrasound's effectiveness in emergency medicine at Hochrhein Hospital, emphasizing its portability, wireless charging, infection control features, and high image quality across various applications. The TEX20's iWorks workflow automation tool also accelerates routine assessments through preset protocols.
unknown
RadAI
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | FDA Radiology AI Device - X-ray Interpreter
The FDA approved the Mindray TEX20 series diagnostic ultrasound systems on November 16, 2021, for a wide range of applications including ophthalmic, fetal, abdominal, cardiac, and musculoskeletal exams. These systems support multiple imaging modes and incorporate AI-assisted tools like Smart Nerve to enhance diagnostic confidence and efficiency.
2021-11
PMC (PubMed Central)
Ultrasonographic Applications of Novel Technologies and Artificial Intelligence in Critically Ill Patients - PMC
This peer-reviewed article discusses the application of AI-guided POCUS in critically ill patients, specifically mentioning the Mindray TEX20 for automatic EF measurement and Smart B-line technology. It highlights how AI can improve the efficiency and effectiveness of ultrasound imaging and aid in assessing fluid responsiveness.
2024-03
FDA
510(k) Premarket Notification - FDA (K220242)
This FDA 510(k) premarket notification from March 25, 2022, confirms that the Mindray TEX20 series Diagnostic Ultrasound System is substantially equivalent to predicate devices. It outlines the device's description, intended use for various patient populations and examinations, and compliance with safety standards.
2022-03
FDA
510(k) Premarket Notification - FDA (K212265)
An FDA 510(k) premarket notification from November 16, 2021, states that the Mindray TEX20 series Diagnostic Ultrasound System is substantially equivalent to its primary predicate device, the Mindray TE7. The document details the intended uses for a broad range of clinical applications and patient demographics.
2021-11

Videos

Product demos, reviews, and walkthroughs for TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System.

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Frequently Asked Questions

The TEX20 series integrates several AI-driven Smart Tools, including AutoEF Plus for automatic ejection fraction calculation, Smart Fluid Management (Smart VTI, Smart IVC, Smart B-line) for efficient fluid assessment, and Smart Echovue for automatic cardiac plane recognition and scanning guidance. Additionally, the X-Pilot suite provides clinical application-oriented workflows to support rapid decision-making in shock, respiration, and trauma assessments by integrating historical data and multi-organ information.
The TEX20 series has received FDA 510(k) clearance, demonstrating its substantial equivalence to predicate devices and compliance with FDA regulations for safety and effectiveness. For data privacy, the system is designed with cybersecurity features like Mindray's M-Secure Suite, which includes advanced encryption and real-time malware protection to safeguard patient data, aligning with general requirements for medical devices handling protected health information under regulations like HIPAA and GDPR.
While specific pricing for the AI features of the TEX20 series is not explicitly detailed as a separate subscription, advanced AI functionalities in ultrasound systems often involve recurring costs such as software licenses or platform fees. The base price for a TEX20 system can vary, with some listings indicating a range from $ to $. Physicians should inquire directly about the total cost of ownership, including any potential subscription models for advanced AI tools.
General limitations of AI in ultrasound include challenges with operator dependency, image variability, and potential biases in algorithms stemming from training data that may lack standardization or diverse representation. While the TEX20's AI tools assist in diagnosis and workflow, human oversight remains crucial for interpretation and decision-making, as AI models can be considered 'black boxes' with limited explainability.
Several other AI-powered diagnostic ultrasound systems are available in the market. These include the Exo Iris with its SweepAIu2122 technology, GE Healthcare's Vscan Air with Caption AIu2122 for guidance and interpretation, and the Clarius HD3 series which offers AI-powered image optimization and automated measurements. Specialized AI solutions like Us2.ai for cardiac analysis and See-Mode for thyroid and breast imaging also exist.
The TEX20 series utilizes its X-Link technology to integrate ultrasound imaging with other physiological data, such as ECG and respiratory waveforms, onto a single, unified display. This AI-enhanced integration, including the Physio-View feature, allows clinicians to effortlessly correlate cardiac and respiratory functions with ultrasound images, providing a more comprehensive view of the patient's condition for real-time decision-making and multidisciplinary treatment.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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