6450 Ultrasound System (MyLabE85)

by Esaote S.p.A.  · Based in Italy → — Expertise for Guided Care
Interventional Radiology Oncology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The Esaote 6450 Ultrasound System (MyLabE85) is an advanced cart-based ultrasound platform engineered for high performance in guided care and interventional procedures. It integrates AI-based automation tools for image optimization and workflow support, aiming to deliver consistent and reliable results. Key features include the ClearWave Architecture, XBeamforming, XSmart Postprocessing, and XCrystal technology for superior image quality. The system is designed to enhance diagnostic assessment and procedural confidence through innovative technologies like Virtual Navigator, which enables real-time multimodality image fusion (CT, MRI, and Ultrasound), and an integrated Ablation Confirmation software for assessing the technical success of thermal ablation procedures. The MyLabE85 GTS Edition offers an ergonomic design with a tiltable 15.6” touchscreen and an optional 24” Barco monitor, along with multiple transducer connectors and battery support for operational flexibility in diverse clinical environments.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based automation tools for image optimization and workflow support
  • Virtual Navigator for real-time multimodality image fusion (CT, MRI, Ultrasound)
  • Ablation Confirmation software for assessing treatment success
  • ClearWave Architecture, XBeamforming, XSmart Postprocessing, and XCrystal technology for high image quality
  • Ergonomic design with tiltable 15.6u201d touchscreen and optional 24u201d Barco monitor
  • Up to 5 active transducer connectors for immediate probe switching
  • Battery support for autonomous scanning at full performance
  • MyLabu2122Remote technology for live streaming and remote control of scanners
  • Advanced vascular imaging with microV technology for low blood flow visualization
  • Elastography (ElaXto, QElaXto, QElaXto 2D) and Contrast-Enhanced Ultrasound (CnTIu2122 Clear) for tissue characterization

Use Cases

  • Ultrasound-guided biopsies, aspirations, and drainages
  • Thermal ablation procedures and treatment confirmation
  • Complex interventional radiology procedures
  • Urological diagnostics, including prostate, testis, and penile imaging
  • Cardiovascular and general imaging examinations
  • Musculoskeletal and women's health applications

What Physicians Need to Know

DICOM Support & Standards
The MyLabE85 system supports comprehensive DICOM services, including downloading worklists, saving images, clips, and Structured Report objects to network storage, CD-R, DVD, USB, and Flash Memory. It also enables printing to networked hardcopy devices and retrieving/displaying Ultrasound, Ultrasound Multiframe, and Secondary Capture objects from media and Query/Retrieve servers. Esaote provides detailed DICOM Conformance Statements.
PACS Integration Method
The system facilitates automatic sending of data to PACS. Esaote's Healthcare IT solutions, such as SUITESTENSA ZefiRO, offer cloud-native PACS with zero-footprint technology, ensuring system-independent access to medical images from any location.
Reading Room Workflow Impact
AI-based automation tools are integrated for image optimization and workflow support, aiming to deliver consistent and reliable results, simplify procedures, reduce keystrokes, and enhance overall usability. Features like automatic synchronization for fusion imaging and advanced body motion compensation streamline interventional workflows and increase efficiency.
AI Model Architecture (deep learning approach)
Esaote's AI, branded as 'Augmented Insightu2122', is built on data-driven machine learning to simplify repetitive gestures, complex procedures, measurements, and lesion analysis across modalities. For breast imaging, the Breast Mass Analyzer (BMA) utilizes a machine learning model based on radiomics to predict BI-RADSu00ae categories.
FDA Clearance Pathway
The 6450 Ultrasound System (MyLabE85) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Supported Modalities
The MyLabE85 is an ultrasound system. Its advanced features include 'Virtual Navigator' for real-time multimodality fusion imaging, combining previously acquired CT, PET-CT, and MRI datasets with live ultrasound for precise guidance in interventional procedures. The AI-supported Ablation Confirmation Suite also analyzes pre- and post-ablation CT scans and multiparametric MRI data.
RSNA/ACR Validation
Esaote actively showcases its innovations, including the MyLabE85 GTS, at major radiology congresses like the European Congress of Radiology (ECR). The AI-powered Breast Mass Analyzer (BMA) supports classification of suspicious breast lesions according to the ACR BI-RADSu00ae category, indicating alignment with ACR standards.
Physician Tip

Leverage the MyLabE85's AI-based automation for consistent image optimization and streamlined workflows, particularly in interventional procedures requiring fusion imaging with CT/MRI. Utilize features like Virtual Navigator for enhanced precision in biopsies and ablations. The AI-driven tools, such as Breast Mass Analyzer, can aid in lesion characterization and potentially reduce unnecessary follow-ups. Familiarize yourself with the system's DICOM and PACS integration capabilities for efficient data management and seamless integration into your existing radiology ecosystem.

The MyLabE85 offers robust DICOM 3.0 compliance for seamless integration with various PACS, RIS, and hospital information systems. Its multimodality fusion capabilities allow for integration with pre-acquired CT, PET-CT, and MRI data, enhancing diagnostic and interventional guidance. Esaote's broader IT solutions, including cloud-native PACS, further support comprehensive clinical data management and remote access.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing — Contact vendor for a personalized quote.
DeploymentOn-premise (cart-based system)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The 6450 Ultrasound System (MyLabE85) received 510(k) Premarket Notification clearance (K241671) from the FDA on May 16, 2025, for use as a general-purpose ultrasound imaging system.

Integrations
EHR Not specified
Specialties Interventional Radiology, Oncology, Radiology

What the Web Says

The Esaote MyLabE85 GTS is a cart-based ultrasound system designed for interventional radiology, emphasizing guided procedures and therapies. It integrates Virtual Navigator and Ablation Confirmation technologies for enhanced precision in biopsies, aspirations, and thermal ablations. The system aims to improve workflow and physician confidence through advanced imaging and AI-based automation.

Overall: Positive

Strengths

  • Excellent needle visualization, boosting physician confidence in surgical precision.
  • Integrated Virtual Navigator and Ablation Confirmation for real-time multimodality fusion imaging (CT, MRI, ultrasound) and treatment verification.
  • AI-based automation tools for image optimization and workflow support, leading to consistent and reliable results.
  • Touch-sensitive, easy-to-clean keyboard and customizable ergonomic design for user comfort and adaptability.
  • High performance in biopsies, aspirations, and drainages.
  • Compact size and mobility, making it easy to transport and adaptable to diverse interventional environments.

Limitations

  • Specific pricing information is not readily available in the provided search results.
  • No direct reviews from Reddit, G2, or Capterra were found, limiting insights into broader user experiences outside of medical publications and company announcements.

Based on reviews from: Medical Product Outsourcing, MedicalExpo, Scribd, AuntMinnieEurope, Esaote, Imaging Technology News, FOVU (First Opinion Veterinary Ultrasound), DAIC, Media OutReach Newswire, healthcare-in-europe.com

Last updated: 2026-07-18

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Press & Coverage

Innolitics (FDA U.S. FOOD & DRUG ADMINISTRATION)
6450 Ultrasound System (MyLabE85) (K253288) u2014 FDA 510(k)
The FDA granted 510(k) clearance to Esaote S.p.A. for their 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) on April 6, 2026. The system is intended for diagnostic ultrasound imaging in various applications including cardiac, vascular, general imaging, and women's health.
2026-04
u5bb6u533bu5927u5065u5eb7
2025u5e74u5ea6u7d22u5f15uff1a100u6b3eu83b7FDAu6279u51c6u7684AIu9a71u52a8u533bu7597u8bbeu5907
The 6450 Ultrasound System (MyLabE85) by Esaote S.p.A. was listed among 100 FDA-approved AI-driven medical devices in 2025, specifically for radiology.
2026-06
FDA
K241671 - 510(k) Premarket Notification - FDA
Esaote S.p.A. received 510(k) premarket notification for the 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) on May 16, 2025.
2025-05
RecallHawk
ESAOTE S.P.A. u2014 FDA Actions | RecallHawk
Esaote S.p.A. has several FDA actions listed, including the 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) with an action date of April 6, 2026.
2026-04
FDA
K253288 - 510(k) Premarket Notification - FDA
This FDA 510(k) premarket notification for the 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) by Esaote, S.p.A. was made public on May 11, 2026.
2026-05
Hardian Health
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System ...
The 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) by Esaote, S.P.A. is identified as an FDA-cleared radiology AI listing for Ultrasound.
unknown

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