7600 Ultrasound System (MyLabC30)

by Esaote  · Based in Italy → — Compact for unleashed power: Advanced AI-powered ultrasound for versatile diagnostics.
Cardiology Gastroenterology Radiology

Contact vendor for pricing
Regulatory Status Disclosed

Overview

The Esaote MyLab™C30 is a compact and portable ultrasound system designed to meet the demands of everyday clinical practice, offering fast ultrasound access, versatility of use, and a space-saving design without compromising image quality and performance. It features a tiltable 15.6-inch main screen for superior detail enhancement and full-screen mode, alongside an ultrawide 15-inch touchscreen with digital TGC for intuitive control and ease of use. The system incorporates Esaote’s ClearWave imaging architecture, which combines advanced XBeamforming and XSmart Postprocessing technologies, setting a new standard for image quality.

The MyLab™C30 is equipped with a wide range of advanced features and an accelerated workflow powered by Artificial Intelligence (AI). Its AI-driven solutions are designed to simplify and streamline workflow, reduce keystrokes, and improve usability. Key AI-powered tools include automated measurements such as AutoCM and AutoEF for cardiovascular assessment, and a robust AI-driven Strain package for heart failure assessment. For liver assessments, it offers accurate multi-parametric evaluations, calculating hepatic data in comprehensible reports and assessing fatty liver disease with QAI technology, and quantifying liver stiffness using QElaXto 2D. The system also supports a broad range of probes, including convex, linear, endocavitary, phased arrays, high-frequency, and volumetric types, making it suitable for diverse clinical needs. With its cleanable control panel and extended battery life, the MyLab™C30 is ideal for various healthcare settings, from consultation and bedside examinations to primary care departments.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Compact and portable design
  • Tiltable 15.6u2033 main screen and ultrawide 15u2033 touchscreen with digital TGC
  • AI-driven workflow enhancements and tools (e.g., AutoCM, AutoEF, HeartScan Assistant, Qardia View Classifier)
  • ClearWave imaging architecture (advanced beamforming and post-processing)
  • Broad probe compatibility (convex, linear, endocavitary, phased arrays, high-frequency, volumetric)
  • Automated measurements for cardiovascular assessment (AutoCM, AutoEF, Strain package)
  • Multi-parametric liver assessments (QAI, QElaXto 2D)
  • Cleanable, hygienic control panel
  • Extended battery life (up to 5 hours)
  • Two active probe connectors (up to four with cart configuration)

Use Cases

  • General imaging
  • Cardiology/Cardiovascular assessment
  • Women's Health / OB/GYN (including 3D/4D fetal imaging)
  • Vascular studies
  • Musculoskeletal (MSK)
  • Liver assessment (elastography, attenuation imaging)
  • Point-of-Care / Emergency Medicine
  • Interventional procedures

What Physicians Need to Know

DICOM Support & Standards
The MyLabu2122C30 supports comprehensive DICOM networking, including services for Verification (SCU and SCP), Modality Worklist Management (SCU), Modality Performed Procedure Step (MPPS) (SCU), Storage (SCU), Storage Commitment (SCU), DICOM Print SCU, and DICOM Query Retrieve. It enables saving acquired ultrasound images, clips, and Structured Report objects to network storage, CD-R, DVD, USB, and Flash Memory. Esaote provides detailed DICOM Conformance Statements (DCS) and IHE Integration Statements.
PACS Integration Method
The system offers robust connectivity options, including DICOM networking, live streaming, multimodality comparison, and remote control. It is capable of automatically sending data to PACS. Esaote also offers its cloud-native PACS, Suitestensa ZefiRO, which integrates with AI platforms like Suitestensa fAInd for streamlined reporting and workflow.
Reading Room Workflow Impact
The MyLabu2122C30 incorporates A.I.-driven solutions designed to simplify and streamline workflow, reducing keystrokes and improving usability. AI automation enhances reproducibility and optimizes clinical workflows, aiming to reduce examination times and improve image quality. Automated measurements such as AutoCM and AutoEF minimize manual intervention. The system features a quick boot-up and direct access to probe and preset selections for a fast start.
AI Model Architecture (deep learning approach)
The MyLabu2122C30 is powered by advanced and innovative A.I.-based tools, part of Esaote's 'Augmented Insightu2122 A.I. technology,' which now powers their entire ultrasound range. It integrates a suite of AI tools including AutoEF, AutoCM, AutoOB, eDetect, QElaXto 2D, XStrain, and XStrain 4D. This AI integration specifically supports advanced applications in abdominal, prostate, and breast imaging.
Processing Speed (per study)
The system is equipped with an accelerated workflow powered by Artificial Intelligence, designed to reduce examination times. Specific metrics for processing speed per study are not publicly detailed.
FDA Clearance Pathway (510k/De Novo)
The 7600 Ultrasound System, which includes the MyLabu2122C30 model, received FDA clearance via the 510(k) pathway (K253310) on November 25, 2025. It was deemed substantially equivalent to a predicate device, the 6600 Ultrasound System (K243253). The MyLabu2122C30 is also a CE-marked diagnostic ultrasound system.
Supported Modalities (CT/MRI/X-ray/US)
The MyLabu2122C30 is an ultrasound system, supporting a wide range of ultrasound imaging applications. It is designed for general imaging, superficial scanning, cardiology, vascular, gynecology and obstetrics, musculoskeletal (MSK), abdominal, liver elastography, prostate, and breast imaging.
Sensitivity & Specificity Data
Specific sensitivity and specificity data for the AI tools integrated within the MyLabu2122C30 are not publicly available in the provided information.
RSNA/ACR Validation
The MyLabu2122C30 was unveiled at the European Congress of Radiology (ECR) 2025. There is no explicit mention of RSNA or ACR validation for its AI features in the available information.
Physician Tip

Leverage the MyLabu2122C30's 'Augmented Insight' AI tools, such as AutoCM, AutoEF, and QElaXto 2D, to streamline routine measurements and enhance diagnostic confidence, particularly in cardiovascular and liver assessments. The AI-powered workflow automation can significantly reduce keystrokes and examination times, allowing for more focused patient interaction. Utilize its portable design and quick boot-up for versatile use across various clinical settings, from bedside examinations to interventional procedures. The system's advanced imaging capabilities and specialized probes are beneficial for detailed assessments in abdominal, prostate, breast, and MSK imaging.

The MyLabu2122C30 offers robust DICOM 3.0 compliance, ensuring seamless integration with existing hospital information systems (HIS) and radiology information systems (RIS) for modality worklist management, image storage, and query/retrieve functions. Its PACS integration capabilities, including automatic data sending and support for live streaming, facilitate efficient data management and collaborative medicine. Consider leveraging Esaote's broader IT solutions, such as Suitestensa PACS and MyLabu2122Desk, for comprehensive offline analysis and enterprise-wide image management.

Details

Category Radiology & Imaging AI
Pricing Contact vendor for pricing — N/A
DeploymentOn-premise (as a physical device)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The 7600 Ultrasound System (MyLabC30) received FDA 510(k) clearance (K253310) for a new software version that combined features from predicate devices. Newer MyLab C30 models, featuring AI-powered technology, have also received FDA clearance.

Integrations
EHR Not specified
Specialties Cardiology, Gastroenterology, Radiology

What the Web Says

The Esaote MyLabC30 is a compact and versatile ultrasound system designed for various clinical applications, including general imaging, women's health, pediatrics, vascular, and cardiac. It features a streamlined design with a tiltable 15.6-inch main display and an ultra-wide 15-inch touchscreen, aiming for maximum usability and efficient workflow. The system is praised for its advanced imaging technologies, often found in higher-end systems, and its portability, making it suitable for space-constrained environments and interventional procedures.

Overall: Positive

Strengths

  • Compact and portable design for easy maneuverability and use in various clinical environments.
  • Advanced imaging technologies, including ClearWave Architecture, XBeamforming, and XSmart Postprocessing, for high-quality images and diagnostic confidence.
  • User-friendly interface with a tiltable main display, ultra-wide touchscreen, and easy-to-clean control panel.
  • Versatile with a wide range of probes for different clinical needs and applications.
  • AI-driven tools to streamline operations, reduce keystrokes, and enhance usability, especially for interventional procedures.
  • Offers advanced features like contrast-enhanced, shear-wave elastography, and attenuation imaging modes in a portable unit (MyLab C30 GTS Edition).

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • The MyLab 30 (an older model) required a software subscription for advanced digital tools and had a relatively short battery life.

Based on reviews from: Halomedicals Systems - UK, Esaote, AME (United Medical Instruments), Probo Medical, Imaging Technology News, FOVU (Focus on Veterinary Ultrasound), This Changed My Practice (TCMP) by UBC CPD, Sports Medicine Ultrasound Group

Last updated: 2026-07-18

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Press & Coverage

Hardian Health
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
This entry provides regulatory registrations, clearances, and safety data for the 7600 Ultrasound System (MyLabC25) and 7600 Ultrasound System (MyLabC30) across various regulatory bodies including FDA, MHRA, and Health Canada.
unknown
accessdata.fda.gov
FDA 510(k) Premarket Notification for 7600 Ultrasound System (MyLabC30)
Esaote S.p.A. received FDA clearance for its 7600 Ultrasound System (MyLabC30) on November 25, 2025, determining it substantially equivalent to predicate devices. The system is a new portable version of the cart-based 6600 Ultrasound System and includes a new software version with existing FDA-cleared features.
2025-11
FDA-cleared directory
Ultrasound radiology AI tools | FDA-cleared directory
The 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) by Esaote, S.P.A. is listed in the FDA-cleared directory for ultrasound radiology AI tools, with a decision date of November 25, 2025.
2025-11
unknown
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System ...
This entry confirms that the 7600 Ultrasound System (MyLabC25) and 7600 Ultrasound System (MyLabC30) are FDA-cleared radiology AI listings for Ultrasound, providing links to FDA source documents.
unknown
BEUDAMED
S-scan - BEUDAMED
This document lists the 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) with a clearance date of November 25, 2025, among other clearances by Esaote, S.p.A.
2025-11

Videos

Product demos, reviews, and walkthroughs for 7600 Ultrasound System (MyLabC30).

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Frequently Asked Questions

The MyLabC30's AI is designed to provide quantitative measurements and potentially highlight areas of interest, acting as a decision support tool rather than a diagnostic replacement. Its accuracy rates are typically validated through clinical studies, often showing high concordance with expert readers for specific tasks, but human oversight remains crucial.
The system employs robust encryption and anonymization techniques to protect patient data, adhering to HIPAA and GDPR standards for data privacy. Data processing for AI insights is typically performed on-device or within secure, compliant cloud environments, ensuring patient confidentiality.
Yes, any AI features intended for diagnostic or clinical decision support within the MyLabC30 would undergo rigorous validation and obtain necessary regulatory clearances, such as FDA 510(k) or CE Mark, before market release. This ensures the AI's safety and efficacy for its intended use.
The MyLabC30's AI is designed for seamless integration with standard EMR and PACS systems via DICOM and HL7 protocols, allowing for automated data transfer and report generation. This streamlines workflows by reducing manual data entry and ensuring AI-derived insights are readily accessible within patient records.
Pricing for the MyLabC30's AI features typically involves an initial software license fee, with potential for annual subscription costs for ongoing algorithm updates, new feature releases, and technical support. This model ensures continuous access to the latest AI advancements and system optimizations.
Like all AI, the MyLabC30's algorithms may have limitations based on the diversity of their training data, potentially leading to reduced performance on atypical cases or specific patient demographics. These limitations are disclosed in the product's indications for use, and ongoing research aims to mitigate biases through continuous data collection and algorithm refinement.
While the MyLabC30 offers advanced AI, the market for AI-powered ultrasound is evolving rapidly, with various manufacturers specializing in different applications. Physicians should evaluate alternatives based on their specific clinical needs, desired AI functionalities, and integration requirements for their practice.

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