V4 Diagnostic Ultrasound System

by Samsung Medison Co.  · Based in South Korea → — Elevating Diagnostic Precision with Next-Generation AI Ultrasound
Cardiology Obstetrics & Gynecology Radiology
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Regulatory Status Disclosed

Overview

The Samsung Medison V4 Diagnostic Ultrasound System is a cutting-edge medical imaging solution designed to enhance diagnostic capabilities across various specialties. It features a world’s first fanless design, which ensures high-performance computing and stable thermal control without a cooling fan, thereby reducing noise, extending lifespan, and blocking external dust. The V4 system integrates advanced AI diagnostic features, powered by Intel Core Ultra processors, to streamline workflows and improve diagnostic accuracy. Its compact design contributes to enhanced mobility and operational efficiency in diverse clinical settings.

The V4 is part of Samsung Medison’s ‘One Platform’ ultrasound brand, offering a consistent user interface and experience, and is equipped with the Windows 11 operating system for flexible functionality expansion and security updates. It is positioned as a powerful and complete solution for essential ultrasound needs, providing superior image quality and advanced features compared to previous models.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • World's first fanless ultrasound diagnostic device for silent operation and extended lifespan
  • AI diagnostic assistance features including Live HeartAssist and NerveTrack
  • High-performance computing and stable thermal control
  • Reduced power consumption by approximately 35% compared to previous models
  • High resolution imaging capabilities
  • Compact design for enhanced mobility and workflow efficiency
  • Advanced image quality for precise diagnostic assessments
  • Automated fetal measurements
  • Tissue stiffness imaging (ElastoScan+u2122)
  • Real-time image sharing solution (SonoSyncu2122) for collaboration
  • Windows 11 operating system for flexible functionality and security

Use Cases

  • General diagnostic imaging
  • Women's health (OB/GYN)
  • Cardiovascular examinations
  • Musculoskeletal assessments
  • Emergency care settings
  • Outpatient and mobile care

What Physicians Need to Know

DICOM Support & Standards
The V4 Diagnostic Ultrasound System, as a modern diagnostic imaging device from Samsung Medison, inherently supports DICOM (Digital Imaging and Communications in Medicine) for handling, storing, printing, and transmitting medical imaging information. This is a fundamental standard for medical imaging devices, enabling seamless integration into healthcare IT environments.
PACS Integration Method
The system is designed for integration with Picture Archiving and Communication Systems (PACS), allowing for efficient archiving, retrieval, and management of ultrasound images and reports. This is a standard capability for modern diagnostic ultrasound systems to support streamlined clinical workflows.
Reading Room Workflow Impact
The V4 system significantly impacts reading room workflow through intelligent automation and AI-powered features. It offers one-click operations for functions like Easy Structure and Easy Flow, reducing examination time by approximately 77% and keystrokes by about 83%. AI diagnostic assistance features such as HeartAssistu2122 and NerveTracku2122 minimize variations in diagnostic results, improving efficiency and consistency regardless of user proficiency.
AI Model Architecture (deep learning approach)
The V4 leverages deep learning technology for its AI applications, including NerveTracku2122 and Live HeartAssistu2122. These applications are optimized using the OpenVINOu2122 toolkit on Intel Core Ultra processors, which feature integrated AI processing engines. This architecture allows for accelerated deep learning inference directly on the device, enhancing real-time AI analytics.
Processing Speed (per study)
AI features like BiometryAssistu2122 automate and standardize fetal measurements in approximately 85 milliseconds with a single click, demonstrating high processing speed for specific tasks. The overall design aims to reduce examination time and keystrokes, contributing to faster study completion.
FDA Clearance Pathway (510k/De Novo)
The V4 Diagnostic Ultrasound System, along with other V-series systems, has received 510(k) premarket notification clearance from the FDA. Specific AI features like BiometryAssist and LaborAssist also received Class 2 FDA clearance in 2020.
Supported Modalities
The V4 is a dedicated Diagnostic Ultrasound System. Its clinical applications are extensive, covering Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac), Peripheral vessel, and Dermatology.
Sensitivity & Specificity Data
For its BiometryAssistu2122 feature, the system provides over 97% accuracy in automating and standardizing fetal measurements. While specific sensitivity and specificity data for all AI features like NerveTracku2122 and HeartAssistu2122 are not publicly detailed, these tools are designed to minimize variations in diagnostic results and improve consistency.
RSNA/ACR Validation
Samsung Medison regularly showcases its diagnostic innovations at major conferences like RSNA. The company's AI tools, such as S-Detectu2122 for Breast (on other Samsung systems), utilize BI-RADS ATLAS* for standardized reporting, which is a registered trademark of the ACR, indicating adherence to established radiological standards.
Physician Tip

Leverage the V4's AI-powered features like HeartAssistu2122 and NerveTracku2122 to reduce diagnostic variability and enhance efficiency, especially in time-sensitive examinations. Utilize BiometryAssistu2122 for rapid and accurate fetal measurements, freeing up time for patient interaction. The intuitive, consistent user interface across Samsung's V-series can minimize training needs when transitioning between systems. Embrace the fanless design for a quieter scanning environment, potentially improving patient comfort and focus during exams.

The V4 Diagnostic Ultrasound System offers robust DICOM support, ensuring seamless integration with existing PACS for image archiving and retrieval. Its architecture, optimized with OpenVINOu2122 on Intel Core Ultra processors, suggests a platform capable of integrating future AI enhancements and potentially connecting with other digital health solutions that leverage standardized data formats. The system's focus on streamlined workflows and data consistency facilitates its role within a broader integrated radiology ecosystem.

Details

Category Radiology & Imaging AI
Pricing Contact for pricing
DeploymentOn-premise (hardware)
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

The V4 Diagnostic Ultrasound System, along with other V-series systems, received 510(k) clearance (K250999) from the FDA on June 17, 2025, indicating it is substantially equivalent to legally marketed predicate devices for its stated indications for use.
Integrations
EHR Not specified
Specialties Cardiology, Obstetrics & Gynecology, Radiology

What the Web Says

The Samsung V4 Diagnostic Ultrasound System is generally well-regarded by physicians and reviewers for its advanced imaging performance, AI diagnostic features, and compact design. It is highlighted as a versatile tool for various medical specialties, including general imaging and women's health, offering streamlined workflows and enhanced diagnostic precision.

Overall: Positive

Strengths

  • Advanced imaging performance and high image quality.
  • AI diagnostic features for various specialties (OB/GYN, cardiac, breast, thyroid, musculoskeletal).
  • Compact and mobile design, enhancing workflow efficiency.
  • Intelligent automation technologies for streamlined diagnostics and reduced scan time.
  • Affordable price point for its capabilities.
  • Versatile for multiple applications including general imaging and women's health.

Limitations

  • Some older Samsung Medison units required adjustments to optimize 4D imaging, which might apply to the V4.
  • Compared to some reference images, the tone can be dark and boundaries expressed as black, requiring user parameter adjustments.
  • Expression of wide areas like the placenta or abdomen can sometimes appear bumpy compared to reference images.
  • Specific detailed physician reviews on Reddit, G2, or Capterra for the V4 system were not readily available, making it difficult to gauge widespread user sentiment from these platforms directly.

Based on reviews from: Scribd (Samsung V4 Ultrasound System Overview, V4 Education Note Share 251223), YouTube (Review of the Samsung V4 Ultrasound Machine), Samsung Healthcare Global, Probo Medical (Samsung Medison Accuvix XG Review), Reddit (r/anesthesiology, r/Sonographers), PubMed (Comparison of four handheld point-of-care ultrasound devices by expert users)

Last updated: 2026-07-19

Ratings & Reviews

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Support & Docs
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Press & Coverage

BigGo Finance
Samsung Medison Unveils Ultrasound Diagnostic Innovation with 'ONE Platform'; Reveals Fanless V4 and Portable EVO Q10
Samsung Medison and Samsung Electronics are set to unveil their 'ONE Platform' at KIMES 2026, featuring AI scalability and a Windows 11-based system. This includes the world's first fanless 'V4' ultrasound system, designed to eliminate noise and improve energy efficiency, and the portable EVO Q10.
2026-03
Scribd (FDA Document)
U.S. Food & Drug - 510(k) Premarket Notification for V8, cV8, V7, cV7, V6, cV6, V5, cV5, V4, and cV4 Diagnostic Ultrasound Systems
The FDA determined on July 18, 2025, that the V4 and cV4 Diagnostic Ultrasound Systems, along with several other V-series models, are substantially equivalent to existing devices, allowing Samsung Medison to market them. These Class II devices are intended for various medical imaging applications and include updated AI models for features like BiometryAssist, ViewAssist, and HeartAssist.
2025-07
accessdata.fda.gov
FDA 510(k) Premarket Notification for V5, H5, XV5, XH5, V4, H4, XV4, XH4 Diagnostic Ultrasound Systems
On December 10, 2024, Samsung Medison received 510(k) clearance for its V4, H4, XV4, and XH4 Diagnostic Ultrasound Systems, which are general-purpose, mobile, software-controlled devices. These systems offer various imaging modes and analysis packages, including AI-based features like BiometryAssist, HeartAssist, ViewAssist, UterineAssist, and NerveTrack.
2024-12
Scribd
V4 Education Note Share 251223
This document outlines Samsung's new V4 Essential ultrasound system, positioning it as a compact, powerful, and complete solution with enhanced image quality and advanced AI features for various medical specialties. It is presented as a next-generation leader in the essential ultrasound market.
2023-12
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
Samsung Medison's V4 and cV4 Diagnostic Ultrasound Systems were among the devices that received 510(k) clearances in 2025, categorized under product codes related to ultrasonic pulsed Doppler imaging systems and automated radiological image processing software.
2026-01
Signify Research
Samsung Ultrasound: AI & Portable Tech Trends 2026
The Samsung V4 system is highlighted as a next-generation portable ultrasound system targeting flexibility in emergency, ICU, and trauma settings, featuring Intel's latest neural processing unit (NPU) and reduced power consumption. The market is shifting towards AI-enhanced diagnostic automation and high-portability devices.
2026-06
FDA.report
FDA 510(k) Applications Received During August, 2024
Samsung Medison Co., Ltd. submitted a 510(k) application for the V4, H4, XV4, and XH4 Diagnostic Ultrasound Systems in August 2024.
2024-08
FDA.report
SAMSUNG MEDISON CO., LTD. FDA Filings
Samsung Medison Co., Ltd. has multiple FDA filings for its V4 Diagnostic Ultrasound System, including various models like H4, XV4, and XH4, with a filing date of December 10, 2024.
2024-12

Videos

Product demos, reviews, and walkthroughs for V4 Diagnostic Ultrasound System.

View all on YouTube

Frequently Asked Questions

The V4 Diagnostic Ultrasound System's AI features are designed to streamline workflow by automating tasks such as measurements, presets, and image optimization, which can reduce examination time and enhance efficiency. It provides AI-driven insights through automated fetal measurements, tissue stiffness imaging, and real-time guidance for image acquisition, assisting in more precise diagnostics and reducing user variability.
The Samsung Medison V4 Diagnostic Ultrasound System has received FDA clearance, indicating it meets the necessary safety and effectiveness standards for marketing in the U.S. For patient data privacy, AI systems like the V4 must comply with HIPAA's Privacy, Security, and Breach Notification Rules, requiring safeguards such as data encryption, access controls, and Business Associate Agreements with third-party vendors. Additionally, manufacturers are expected to provide detailed documentation on AI algorithms, their limitations, and potential biases to ensure responsible use and compliance with evolving regulations like the EU's IVDR.
The V4 Diagnostic Ultrasound System, like other advanced systems, offers AI features for enhanced imaging and workflow efficiency, particularly in general imaging and women's health. Key differentiators among AI-powered ultrasound solutions often include the specific AI algorithms for guided scanning, automated measurements, image quality enhancement, and the system's portability or specialized application focus, such as cardiac or musculoskeletal imaging. Competitors like GE Healthcare, Philips, Butterfly, and Mindray also offer various AI-enabled systems with unique features and price points.
The cost of ultrasound systems, including those with advanced AI features like the V4, can vary significantly, ranging from approximately $3,000 for portable point-of-care devices to over $120,000 for high-tier cart-based systems. The total cost structure typically includes the initial purchase price, potential additional fees for AI software licensing or subscriptions, and ongoing expenses for maintenance, service contracts, and software upgrades. Specific pricing for the V4 system would need to be obtained directly from Samsung Medison or authorized distributors, as it depends on configurations and included AI packages.
Common limitations of AI in diagnostic ultrasound include operator dependency, image variability across different machines and users, and potential biases if training data is not diverse enough. AI algorithms can also lead to high false positive rates, particularly in tumor detection, emphasizing that AI should serve as a complementary tool rather than a replacement for human expertise. Manufacturers are expected to provide documentation outlining how AI algorithms make decisions, their limitations, and potential biases to ensure informed clinical use.
AI-powered systems like the V4 must adhere to stringent data security protocols to protect patient data, especially Protected Health Information (PHI). This includes implementing end-to-end encryption for data in transit and at rest, robust access controls, and regular auditing of all access attempts. Furthermore, any third-party AI vendors involved must be HIPAA-compliant and have a signed Business Associate Agreement (BAA) in place to ensure shared responsibility for data protection.
Effective utilization of AI-powered ultrasound systems like the V4 requires comprehensive training and ongoing support for physicians. This often includes on-system tutorials, guided protocols, and real-time feedback from the AI to help clinicians interpret scans accurately and reduce the learning curve. Manufacturers typically offer training programs and technical support to ensure users can maximize the benefits of AI features and understand their outputs within clinical practice.

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