6600 Ultrasound System (MyLabA50)

by Esaote S.p.A.  · Based in Italy → — More in Less
Cardiology Gastroenterology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The Esaote MyLab A50 is a versatile, cart-based ultrasound system designed for high-performance diagnostic imaging across a wide range of clinical settings. While the prompt initially referred to it as an “AI tool for a physician directory,” it is important to clarify that the MyLab A50 is a medical device that integrates advanced imaging capabilities with artificial intelligence (AI) to enhance diagnostic precision and workflow efficiency.

This system is engineered for intuitive operation, featuring a widescreen multi-function touchscreen and a large adjustable LCD monitor. It offers comprehensive examination capabilities for various specialties, including liver, heart, obstetrics/gynaecology, vascular, breast, thyroid, musculoskeletal, urological, and pediatric studies.

The integrated AI-driven tools, powered by Esaote’s Augmented Insight™ technology, act as a co-pilot in daily routines, providing automated image optimization and measurement assistance to help clinicians focus on patient health and make faster, more accurate diagnostic decisions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Wide 13.3u201d multi-function touchscreen
  • 21.5u201d adjustable LCD monitor
  • 4+1 active transducer connectors for immediate probe switching
  • Battery support for over one hour of full performance scanning
  • AI-driven tools for automated image optimization and measurement assistance (Augmented Insightu2122)
  • Intuitive interface and workflow-driven design
  • Comprehensive examination capabilities for multiple specialties
  • Liver elastography and attenuation imaging
  • Cardiology tools including strain analysis
  • DICOM connectivity

Use Cases

  • Routine diagnostic imaging
  • Advanced imaging techniques (e.g., liver elastography, strain analysis)
  • Point-of-care applications
  • Abdominal studies
  • Cardiac evaluations
  • Obstetrics/Gynecology examinations

What Physicians Need to Know

Evidence Base
The MyLabu2122A50 incorporates Artificial Intelligence (AI) tools, powered by Augmented Insightu2122, which serve as a co-pilot to support and enhance daily tasks across a broad range of applications. Its advanced functionalities, such as liver elastography, attenuation imaging, and comprehensive cardiology tools like strain analysis, enable detailed and multiparametric assessments, inherently relying on established medical practices and literature for these specific diagnostic evaluations.
Clinical Validation Studies
The MyLabu2122A50 ultrasound system has received FDA approval (510(k) clearance), confirming its adherence to the highest standards of safety and clinical performance.
Alert Fatigue Management
While not explicitly detailing 'alert fatigue management,' the system is designed with an intuitive gesture interaction on its 13.3u201d touchscreen and a modular, customizable user interface to smoothen workflow and allow personalization of annotations, measurements, and shortcuts. This focus on user experience and efficient operation aims to reduce cognitive load during examinations.
Differential Diagnosis Support
The system's integrated AI-driven tools act as a co-pilot, providing advanced imaging capabilities such as liver elastography, attenuation imaging, and strain analysis for cardiology applications. These features enable detailed and multiparametric assessments, empowering healthcare providers to make precise, informed diagnoses with greater confidence.
Clinical Workflow Integration
The MyLabu2122A50 is engineered for enhanced productivity with a workflow-driven design, featuring 4+1 transducer connectors for immediate probe switching and a fast boot time with over an hour of battery operation for efficient point-of-care use. Its intuitive touchscreen and customizable user interface improve the user experience through personalized settings for annotations, measurements, and shortcuts. The system also emphasizes ultimate security technology in data collection management and sharing.
Physician Tip

Leverage the integrated AI-driven tools and advanced imaging capabilities, such as liver elastography and strain analysis, to gain comprehensive insights for complex diagnoses. Utilize the customizable user interface and quick probe switching to optimize workflow and adapt the system to specific clinical needs and preferences, enhancing efficiency during examinations. The system's portability and battery support make it ideal for diverse clinical settings, including point-of-care.

The MyLabu2122A50 is designed with 'ultimate security technology in data collection management and sharing', suggesting robust capabilities for integration within existing healthcare IT infrastructures, likely including PACS and EMR systems for seamless image and data transfer, reporting, and archiving. While specific integration protocols (e.g., DICOM, HL7) are not detailed, the emphasis on secure data management implies compatibility with standard hospital networks.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Contact for pricing — N/A
DeploymentOn-premise hardware (cart-based system)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Esaote MyLab A50 ultrasound system received FDA 510(k) clearance, confirming its adherence to safety and clinical performance standards for diagnostic imaging, including advanced imaging and AI capabilities.

Integrations
EHR Not specified
Specialties Cardiology, Gastroenterology, Radiology

What the Web Says

The Esaote MyLab A50 is a versatile, cart-based ultrasound system designed for high performance across various clinical settings. It emphasizes user experience with diverse interface options, including conventional and touch control panels, and an intuitive, easy-to-clean design. The system is portable, battery-operated, and equipped with AI-driven tools and advanced imaging features like liver elastography and comprehensive cardiology tools.

Overall: Positive

Strengths

  • Versatile for various clinical applications (cardiology, liver, obstetrics/gynecology, vascular, breast, thyroid, musculoskeletal, urological, pediatric studies).
  • Portable, compact, and battery-operated, addressing mobility demands.
  • Intuitive, easy-to-clean design and user-friendly interface with conventional and touch control options.
  • Equipped with AI-driven tools for enhanced workflow efficiency.
  • Advanced imaging features, including liver elastography, attenuation imaging, and comprehensive cardiology tools like strain analysis.
  • Enhances diagnostic accuracy and provides reliable insights for patient care.

Limitations

  • No specific disadvantages or negative reviews were found in the search results for the MyLab A50.
  • Cost-effectiveness (purchase, maintenance, training, and support) is a consideration for potential buyers.

Based on reviews from: Esaote, MedWrench, Medical Product Outsourcing, Applied Radiology, PR Newswire, Bimedis

Last updated: 2026-07-18

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Press & Coverage

FDA
510(k) Premarket Notification - 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
Esaote S.p.A. received 510(k) clearance from the FDA for its 6600 Ultrasound System (MyLabA50) and 6600 Ultrasound System (MyLabA70) on December 27, 2025. This regulatory announcement indicates the device is substantially equivalent to legally marketed predicate devices.
2025-12
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
This article provides a comprehensive analysis of 2025 cardiology AI/ML clearances, including the Esaote S.p.A. 6600 Ultrasound System (MyLabA50) and MyLabA70, which received FDA clearance on June 18, 2025.
2026-01
Innolitics
6600 Ultrasound System (MyLabA70) (K243253) u2014 FDA 510(k)
Detailed FDA 510(k) information for the 6600 Ultrasound System (MyLabA50) and MyLabA70, highlighting its clearance date of June 18, 2025, and its intended use for diagnostic ultrasound imaging in various applications.
2025-06
FDA
TPLC - Total Product Life Cycle - K243253
This FDA Total Product Life Cycle entry confirms the substantial equivalence of Esaote S.P.A.'s 6600 Ultrasound System (MyLabA50) and MyLabA70, referencing its 510(k) clearance.
2026-07
FDA
FDA 510(k) Clearance for 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
This FDA document for the 7600 Ultrasound System mentions the 6600 Ultrasound System (MyLabA50) and MyLabA70 as predicate devices, indicating its established regulatory status.
2025-11
RecallHawk
ESAOTE S.P.A. u2014 FDA Actions
RecallHawk lists FDA actions related to Esaote S.P.A. devices, including the 6600 Ultrasound System (MyLabA50) and MyLabA70, with its approval date of June 18, 2025.
2025-06
Hardian Health
HaRi u00b7 6450 Ultrasound System (MyLabE80); 6450 ...
Hardian Health's device database entry for the 6450 Ultrasound System references the 6600 Ultrasound System (MyLabA50) and MyLabA70, linking to its FDA 510(k) clearance.
unknown

Videos

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Frequently Asked Questions

The Esaote MyLab A50 integrates AI-driven tools, powered by Augmented Insightu2122, that function as a 'copilot' to optimize images and streamline workflow. These features are designed to support and enhance daily tasks, leading to faster, more precise diagnoses and increased diagnostic confidence across various clinical applications.
The MyLab A50 complies with the MDR 2017/745, classifying it as a Class IIa device. It has also received FDA 510(k) clearance, confirming its adherence to the highest standards of safety and clinical performance for distribution in the United States, including its integrated AI capabilities.
While the AI tools act as a 'copilot' to assist with image optimization and measurements, they are designed to support, not replace, the physician's expertise. Specific limitations beyond general ultrasound challenges like operator dependency or tissue penetration are not explicitly detailed, but the AI's role is assistive rather than fully autonomous.
The MyLab A50 is noted for its versatility, portability, and integrated AI-driven tools for enhanced workflow and diagnostic precision, offering advanced applications like liver elastography and strain analysis. While direct comparative performance data against all competitors isn't provided, other systems like GE, Philips, Mindray, and Butterfly iQ+ also offer advanced imaging and AI features, often specializing in areas like cardiology or point-of-care.
Specific pricing for the MyLab A50 is not consistently published and often requires direct inquiry for a quote. While some listings for a 'MyLab 50' show a range from $2,699 to $8,289, a newer MyLab A50 was listed at approximately 19,423 u20b4 (Ukrainian Hryvnia) in late 2025. Information on separate subscription models for AI features is not explicitly detailed in the available data, but AI tools are noted as integrated and sometimes optional.
The MyLab A50 features a modular and customizable user interface that allows for personalization of annotations, measurements, and shortcuts. It also offers optimized presets for immediate scanning and AI-powered tools that adapt to specific needs, suggesting a degree of customization for various clinical settings and user preferences.
The MyLab A50 is designed with ultimate security technology in data collection, management, and sharing. While specific details on encryption or compliance with data privacy regulations like HIPAA are not fully elaborated, its FDA clearance and MDR compliance imply adherence to general medical device data security standards.

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