6450 Ultrasound System (MyLabE80)

by Esaote S.p.A.  · Based in Italy → — Expertise for Every Care
Gastroenterology Radiology Urology

Contact for pricing
Regulatory Status Disclosed

Overview

The Esaote MyLab™E80 is an advanced AI-enabled ultrasound system meticulously crafted to provide unparalleled expertise in examinations and seamlessly adapt to diverse clinical environments. It aims to deliver reliable and accurate information while minimizing inter-operator bias through intuitive workflow design and automation features enhanced by artificial intelligence.

Powered by Esaote’s ClearWave Architecture, which combines advanced XBeamforming and XSmart Postprocessing technologies, the MyLab™E80 sets a new benchmark for image quality. It integrates AI-powered Augmented Insight™ tools to standardize measurements and reduce operator variability, offering features like automatic contouring, metric standardization, and lesion scoring (e.g., BI-RADS®). The system supports fusion imaging technology, high-sensitivity Doppler modes (microV, BrightFlow), and a comprehensive portfolio of high-performance probes.

Designed for efficiency and diagnostic precision, the MyLab™E80 features an ergonomic control with a tiltable 15.6” ultrawide touchscreen, optional 24” OPTI-LIGHT monitor, and two control panel configurations (conventional or cleanable). It includes five active transducer connectors for immediate probe switching and offers battery support for over an hour of full-performance scanning, ensuring adaptability in fast-paced settings. The system also boasts networking capabilities to simplify data workflow and facilitate the sharing of clinical information.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • ClearWave Architecture for superior image quality
  • AI-powered Augmented Insightu2122 for automated measurements and reduced variability
  • Fusion imaging technology (e.g., LiverFusion, UroFusion, MRI/US fusion)
  • High-sensitivity Doppler modes (microV, BrightFlow, CFM)
  • Ergonomic design with tiltable 15.6u201d ultrawide touchscreen
  • Dual control panel options (conventional or cleanable)
  • Five active transducer connectors for rapid probe switching
  • Battery support for over one hour of full-performance scanning
  • Breast Interactive Workflow (BIW) with Breast Mass Analyser (BMA) and eDetect AI-based technologies
  • Automatic contouring and measurements for lesions (e.g., BI-RADSu00ae scoring, thyroid masses)

Use Cases

  • Liver disease assessment and characterization
  • Breast lesion characterization and scoring
  • Musculoskeletal disease diagnosis and follow-up
  • Cardiovascular examinations and strain analysis
  • Urological diagnostics, including prostate imaging and biopsies
  • Thyroid mass analysis with automatic contouring

What Physicians Need to Know

DICOM Support & Standards
The MyLabE80 supports DICOM services for worklist download, saving Ultrasound, Ultrasound Multiframe, and Secondary Capture images, clips, and Structured Report objects to network storage, CD-R, DVD, USB, and Flash Memory. It also enables printing images and retrieving/displaying objects from media and Query/Retrieve servers. A DICOM Conformance Statement (DCS) is available.
PACS Integration Method
The system integrates with PACS via DICOM services, including Modality Worklist management (SCU), Modality Performed Procedure Step (MPPS) (SCU), and Storage service (SCU and SCP for query retrieve). Images can be stored 'on the fly' or manually.
Reading Room Workflow Impact
AI-driven automation, specifically 'Augmented Insight' technologies, aims to standardize measurements, reduce operator variability, and streamline workflows by expediting repetitive tasks and simplifying complex functions. AI-powered auto measurements minimize manual interventions.
AI Model Architecture (deep learning approach)
The MyLabE80 incorporates 'Augmented Insight' AI-powered solutions. Specific AI features include Breast Mass Analyser (BMA) and eDetect technologies for breast lesion evaluation with BI-RADSu00ae scoring, automatic lesion contouring and measurements (BMA is powered by DeepTrace, an AI machine learning model based on radiomics). It also features UroFusion technology for AI-driven prostate navigation with US and MRI segmentation and automatic registration, and automatic contouring and cross-dimensions of thyroid masses.
FDA Clearance Pathway (510k/De Novo)
The 6450 Ultrasound System (MyLabE80) has received 510(k) Premarket Notification clearance from the FDA.
Supported Modalities (CT/MRI/X-ray/US)
The MyLabE80 is an ultrasound system. It supports advanced ultrasound imaging across various applications. It also features fusion imaging technologies, such as LiverFusion and MRI/US fusion, allowing integration with MRI data for enhanced diagnostic capabilities.
RSNA/ACR Validation
The system utilizes BI-RADSu00ae scoring for breast lesion analysis, which incorporates the American College of Radiology's Breast Imaging Reporting and Data System ATLAS. There is no explicit mention of direct RSNA or ACR validation of the MyLabE80 system or its AI algorithms.
Physician Tip

Leverage the MyLabE80's AI-powered 'Augmented Insight' tools for standardized measurements and reduced operator variability, particularly in breast (BI-RADSu00ae scoring, automatic contouring), prostate (UroFusion for US/MRI registration), and thyroid imaging (automatic contouring). The fusion imaging capabilities, especially with MRI, can provide comprehensive insights for complex cases like liver disease and prostate navigation. Utilize the high-sensitivity Doppler modes for detailed vascular assessment. The intuitive workflow and automation features are designed to streamline examinations, allowing for increased focus on patient care.

The MyLabE80 offers robust DICOM 3.0 compliance, ensuring seamless integration with existing PACS and RIS for worklist management, image archiving, and structured reporting. Its ability to perform MRI/US fusion imaging highlights its capacity to integrate and utilize data from other modalities, enhancing diagnostic confidence and planning. Esaote also provides a DICOM Conformance Statement for detailed interoperability planning.

Details

Category Radiology & Imaging AI
Pricing Contact for pricing — Not publicly available; contact Esaote sales for a quote.
DeploymentOn-premise hardware
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The 6450 Ultrasound System (MyLabE80) and MyLabE85 received FDA 510(k) clearance (K241671) on May 16, 2025, classified as a Pulsed Doppler Ultrasonic Imaging System.

Integrations
EHR Not specified
Specialties Gastroenterology, Radiology, Urology

What the Web Says

The Esaote 6450 Ultrasound System (MyLabE80) is a high-end ultrasound platform designed for complex clinical cases, emphasizing diagnostic precision and efficiency. It features AI-powered automation, fusion imaging technology, and an intuitive workflow to enhance diagnostic capabilities and streamline repetitive tasks. The system is adaptable to various healthcare environments, offering configurations for both routine and advanced examinations.

Overall: Positive

Strengths

  • AI-powered automation for streamlined workflow and efficiency.
  • Fusion imaging technology, particularly useful for liver disease and breast lesions.
  • High-resolution, real-time images for precise diagnostics.
  • Intuitive workflow design minimizes inter-operator bias.
  • Adaptable to various clinical environments with five probe connectors and custom configurations.
  • Offers both conventional and touchscreen control panel options.

Limitations

  • No specific cons were identified in the provided search results.
  • No direct physician reviews or opinions were found, only promotional material and product descriptions.
  • No reviews from healthcare IT, tech reviewers, Reddit, G2, or Capterra were found.

Based on reviews from: Esaote, RAD Magazine, CAmed Medical Systems GmbH, PR Newswire, Halomedicals Systems, FDA, PubMed Central (PMC)

Last updated: 2026-07-19

Ratings & Reviews

Rate 6450 Ultrasound System (MyLabE80)

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Innolitics
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) K253288
Esaote's 6450 Ultrasound System (MyLabE80 and MyLabE85) received FDA 510(k) clearance on April 6, 2026. This system is a general-purpose diagnostic ultrasound device that includes an AI-based UroFusion feature for prostate imaging.
2026-04
Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos
This report highlights FDA authorizations for AI/ML devices in Q2 2026, including Esaote's 6450 Ultrasound System (MyLabE80) which was cleared on April 7, 2026. The system is categorized under Radiology and uses AI/ML attributes.
2026-07
FDA
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) K241671
Esaote S.p.A. received 510(k) premarket notification for their 6450 Ultrasound System (MyLabE80 and MyLabE85) on May 16, 2025. The device is classified under Radiology and is a traditional submission.
2025-05
Grand View Research
AI In Radiology Market Size And Share Report, 2026-2033
This market report mentions the FDA 510(k) clearance of Esaote S.p.A.'s 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) on May 16, 2025, as part of the growing regulatory approvals propelling the AI in radiology market.
2026-07
Hardian Health
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote, S.p.A.'s 6450 Ultrasound System (MyLabE80 and MyLabE85) is a general-purpose diagnostic ultrasound system designed for use in professional healthcare facilities. It includes an AI-based UroFusion feature for prostate imaging.
2026-04
accessdata.fda.gov
November 25, 2025 Esaote S.p.A Antonia Perrella Regulatory Affairs Leader Via Enrico Melen 77 Genova, 16152 Italy Re: K253310
This FDA document details a 510(k) premarket notification for Esaote's 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85), noting that no new functionalities were introduced in the software release compared to the previously cleared version.
2025-11

Videos

Product demos, reviews, and walkthroughs for 6450 Ultrasound System (MyLabE80).

Loading videos...

View all on YouTube

No FAQs available yet for this tool.

Related Tools

ScreenPoint Medical
ScreenPoint Medical
Clinical Decision Support & Reference
ScreenPoint Medical offers Transpara, an AI-powered solution for breast cancer detection and diagnosis in mammography and digital breast tomosynthesis, designed to assist radiologists.
Microsoft Azure AI (with BAA)
Microsoft Azure AI
Clinical Decision Support & Reference
Microsoft Azure AI offers a secure, HIPAA-compliant platform with BAA support for developing and deploying AI solutions across the healthcare industry, from clinical decision support to research.
Google Cloud AI (with BAA)
Google
Clinical Decision Support & Reference
Google Cloud AI provides a powerful suite of machine learning and AI tools developed to help healthcare businesses optimize operations, gain insights from data, and enhance patient care. It offers solutions for improved diagnostics, personalized treatment, workflow automation, and cost optimization, all built on a secure and compliant platform.
AI Orchestrator
GE HealthCare
Practice Management & Scheduling
GE HealthCare's AI Orchestrator integrates and manages AI applications within a healthcare imaging ecosystem to streamline workflows and improve diagnostic accuracy.
AI-enabled Ultrasound Technology (licensed to Butterfly Network)
Butterfly Network
Clinical Decision Support & Reference
An FDA-cleared AI-enabled ultrasound technology that estimates fetal gestational age from standardized 'blind sweep' ultrasound videos, expanding access to essential obstetric care.
4DMedical (Imbio)
4DMedical
Cardiology AI
4DMedical, with its acquisition of Imbio, offers a comprehensive suite of AI-driven medical imaging solutions for chronic lung and cardiothoracic diseases, providing quantitative and personalized insights from X-ray and CT scans.

See all Radiology & Imaging AI tools →

More from Esaote S.p.A.

6440 MyLabX90
Esaote S.p.A.
Cardiology AI
Esaote MyLab™X90 is a premium AI-powered ultrasound system designed for advanced medical diagnostics, offering outstanding image quality and intelligent workflow solutions across various clinical applications.
6450 Ultrasound System (MyLabE85)
Esaote S.p.A.
Radiology & Imaging AI
The Esaote MyLabE85 is an advanced AI-powered cart-based ultrasound system offering real-time image fusion, ablation confirmation, and enhanced diagnostics for precise interventional and general imaging procedures.
6600 Ultrasound System (MyLabA50)
Esaote S.p.A.
Clinical Decision Support & Reference
The Esaote MyLab A50 is an advanced, cart-based ultrasound system that combines high-performance diagnostic imaging with integrated AI-driven tools for automated image optimization and measurement assistance across diverse clinical applications.
7600 Ultrasound System (MyLabC25)
Esaote S.p.A.
Radiology & Imaging AI
The MyLab™C25 is a portable ultrasound system from Esaote, designed for everyday clinical practice, offering rapid access to ultrasound, flexibility, and high-quality imaging in a compact form.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
AI Tool Finder
AI-powered search. Results may not be comprehensive.