cV4 Diagnostic Ultrasound System

by Samsung Medison Co.  · Based in South Korea → — Unifying performance and intelligence for diagnostic confidence.
Maternal-Fetal Medicine Obstetrics & Gynecology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The Samsung Medison cV4 Diagnostic Ultrasound System is a state-of-the-art, mobile, software-controlled diagnostic ultrasound system designed to enhance clinical confidence and workflow efficiency across various medical specialties. Part of Samsung’s ‘One Platform’ V-series, the cV4 leverages advanced semiconductor and computing technologies, integrating scalable AI features for superior imaging and streamlined operations.

It is engineered to acquire and display ultrasound data in multiple modes, including 2D, M-mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Doppler, and advanced 3D/4D imaging. The system incorporates Samsung’s proprietary Crystal Architecture™, which combines CrystalBeam™ for innovative beamforming and CrystalLive™ for sophisticated image processing, resulting in crystal-clear, high-resolution images with enhanced penetration.

A notable innovation, the cV4 is recognized as the world’s first fanless ultrasound system, which eliminates fan noise, prevents dust ingress, extends the device’s lifespan, and reduces power consumption by approximately 35% compared to previous models. Running on the Windows 11 operating system, it offers flexibility for long-term functionality expansion and robust security updates. The system is equipped with comprehensive cybersecurity features, including Windows Defender Antivirus, EMR/DICOM Secure Transmission (DICOM TLS), Secure Erase for PHI Data, SSD Encryption (BitLocker), and Audit Trails, ensuring the protection of sensitive patient information.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Crystal Architectureu2122 (CrystalBeamu2122 & CrystalLiveu2122) for enhanced image quality
  • AI-powered HeartAssistu2122 for automated fetal heart assessment
  • AI-powered NerveTracku2122 for real-time nerve detection
  • AI-powered BiometryAssistu2122 for automated fetal measurements
  • AI-powered LaborAssistu2122 for fetal angle of progression estimation
  • World's first fanless design for silent operation and extended lifespan
  • DICOM 3.0 compatibility for seamless image management
  • Comprehensive cybersecurity: Windows 11 OS, SSD encryption (BitLocker), DICOM TLS, Audit Trails
  • S-Vue Transduceru2122 technology for clear, uniform, high-resolution images
  • MV-Flowu2122 for visualizing microcirculatory and slow blood flow

Use Cases

  • Comprehensive fetal and obstetric examinations
  • General abdominal and gynecological diagnostics
  • Cardiac assessment for adult and pediatric patients
  • Musculoskeletal and vascular imaging
  • Urological diagnostics and procedures
  • Point-of-care imaging in various clinical environments

What Physicians Need to Know

ECG/EKG Analysis Capability
The cV4's HeartAssistu2122 AI feature can leverage ECG signals to automatically identify cardiac phases and detect E and A waves, enhancing accuracy, particularly in patients with arrhythmias.
Echocardiography AI Features
The cV4 Diagnostic Ultrasound System incorporates HeartAssistu2122 and Live HeartAssist, AI-powered solutions that automate view classification and cardiac measurements in adult transthoracic echocardiography and fetal heart assessment. These features support 20 echocardiographic views and deliver high accuracy rates (up to 98% for view classification and 95u2013100% for measurements). HeartAssistu2122 automates phase selection, including end-diastole and end-systole, and performs multi-cycle measurements for parameters such as left ventricular volume, wall thickness, and Doppler flow velocities. The system also features an updated 'Strain+' function, expanding its measurement items to include the left atrium (LA) and right ventricle (RV).
Arrhythmia Detection Accuracy
While the cV4 is an ultrasound system, its HeartAssistu2122 AI, when used with ECG, can accurately identify cardiac phases even in the presence of arrhythmias, which is crucial for precise measurements.
Heart Failure Risk Prediction
The cV4 provides accurate quantitative assessment of cardiac structure and function, including left ventricular volume and wall thickness, which are essential data points for clinicians in assessing heart failure risk and guiding management.
Cardiac Monitoring Integration
The expanded HeartAssistu2122 feature supports real-time monitoring of cardiovascular conditions, particularly during pregnancy, indicating integration capabilities for continuous cardiac assessment.
AHA/ACC Guideline Alignment
HeartAssistu2122 facilitates multi-cycle measurements, which are designed to address inter-beat variability and align with clinical guidelines for accurate cardiac assessment, reducing the need for tedious manual processes.
Real-Time Alert Capability
The system's AI functions, such as HeartAssistu2122, enable real-time analysis and measurement assistance, which can contribute to timely identification of critical cardiovascular conditions during examinations, especially in fetal care.
Physician Tip

Leverage HeartAssistu2122 for significant workflow efficiency gains, reducing manual keystrokes by up to 93% and measurement time by 90%. Utilize its multi-cycle measurement capabilities to ensure adherence to clinical guidelines and reduce inter-observer variability, leading to more reproducible and dependable results. For optimal accuracy in complex cases or with arrhythmias, integrate available ECG signals to enhance AI-driven cardiac phase detection. The Live HeartAssist feature is particularly beneficial for rapid and accurate fetal heart assessments.

The cV4 Diagnostic Ultrasound System is part of Samsung Medison's 'One Platform' ultrasound brand, ensuring a consistent user interface and experience across the V Series. Its AI features, including HeartAssistu2122, are built on deep learning algorithms and are integrated into the system, leveraging Intelu00ae Coreu2122 Ultra processors for real-time AI analytics. While primarily an ultrasound system, its AI capabilities can be enhanced by external ECG input for more precise cardiac phase detection.

Details

Category Cardiology AI, OB/GYN AI, Radiology & Imaging AI
Pricing Contact for pricing — Varies by configuration, optional features, and regional distribution agreements.
DeploymentOn-premise (physical hardware device)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The cV4 Diagnostic Ultrasound System, along with other V-series systems, received FDA 510(k) clearance (K250999) for a wide range of clinical applications including Fetal/Obstetrics, Abdominal, Gynecology, and Cardiac. The decision date for clearance was June 17, 2025, with the official letter issued on July 18, 2025.

Integrations
EHR Not specified
Specialties Maternal-Fetal Medicine, Obstetrics & Gynecology, Radiology

What the Web Says

The Samsung Medison cV4 Diagnostic Ultrasound System is an AI-enabled, versatile ultrasound machine primarily designed for obstetrics, gynecology, and maternal-fetal medicine, though it also offers applications in general radiology and some cardiology. A key innovation is its fanless design, which contributes to a quieter clinical environment and potentially extends the device's lifespan. The system emphasizes enhanced image quality through its 'Crystal Architectureu2122' and incorporates AI-powered features to streamline workflows and improve diagnostic confidence.

Overall: Positive

Strengths

  • World's first fanless design provides a quieter operating environment and potentially extends lifespan.
  • Enhanced image quality through 'Crystal Architectureu2122' for diagnostic precision.
  • Versatile for diverse clinical applications, excelling in OB/GYN and fetal assessment.
  • AI-powered features like HeartAssistu2122 and BiometryAssistu2122 streamline fetal assessments and enhance diagnostic confidence.
  • Robust enterprise readiness and data security features, including Windows 11 OS, SSD encryption (BitLocker), DICOM TLS, and audit trails.
  • Real-time AI-powered assists for fetal assessment and nerve detection.

Limitations

  • Pricing information is not readily available and requires direct contact.
  • Lacks objective performance metrics for image quality compared to some specialized systems.
  • No ratings yet on platforms like Physician Ai Tools, G2, or Capterra.
  • Specialized AI capabilities cater to distinct primary clinical needs, making it less ideal for practices solely focused on other areas like advanced cardiovascular imaging.

Based on reviews from: Physician Ai Tools, accessdata.fda.gov, Scribd, Samsung Medison, Samsung Healthcare

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

FDA
510(k) Premarket Notification - FDA
Samsung Medison's cV4 Diagnostic Ultrasound System, along with several other V-series models, received 510(k) premarket notification clearance from the FDA on July 18, 2025, indicating it is substantially equivalent to existing legally marketed devices.
2025-07
Innolitics
cV4 Diagnostic Ultrasound System (K250999) u2014 FDA ... - Innolitics
This entry details the FDA 510(k) clearance for the cV4 Diagnostic Ultrasound System, confirming its regulatory classification and identification.
2025-07
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
The cV4 Diagnostic Ultrasound System is mentioned in a comprehensive analysis of 2025 cardiology AI/ML clearances, highlighting market trends and regulatory insights.
2026-01
Physician AI Tools
cV4 Diagnostic Ultrasound System vs uMI Panvivo - Physician Ai Tools
This article compares the AI capabilities of the cV4 Diagnostic Ultrasound System with the uMI Panvivo PET/CT system, noting the cV4's specialized AI features for OB/GYN and maternal-fetal medicine.
2026-06
FDA.report
Automated Radiological Image Processing Software QIH - FDA.report
The cV4 Diagnostic Ultrasound System is listed under product code QIH for Automated Radiological Image Processing Software, with Samsung Medison Co., Ltd. as the manufacturer.
2025-09
Scribd
Samsung V4 Ultrasound System Overview | PDF - Scribd
This overview highlights the Samsung V4 ultrasound system's advanced imaging performance and AI diagnostic features for various medical specialties, including women's health, emphasizing its compact design and intelligent automation.
2025-03
Scribd
July 18, 2025: U.S. Food & Drug | PDF | Medical Ultrasound - Scribd
This document confirms the FDA's determination that the cV4 Diagnostic Ultrasound System, among others, is substantially equivalent to existing devices, allowing Samsung Medison to market it.
2025-07
FDA
Establishment Registration & Device Listing - FDA
The cV4 Diagnostic Ultrasound System is included in Samsung Medison Co., Ltd.'s establishment registration and device listing with the FDA.
2026-06

Videos

Product demos, reviews, and walkthroughs for cV4 Diagnostic Ultrasound System.

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Frequently Asked Questions

The cV4's AI enhances diagnostic accuracy by providing real-time image analysis, automated measurements, and anomaly detection, which can streamline workflow and reduce scan times. It acts as a decision support tool, highlighting areas of interest and reducing human error and inter-operator variability.
The cV4 Diagnostic Ultrasound System has received U.S. FDA 510(k) clearance, indicating its compliance as a Class II medical device. It incorporates robust security measures, including encryption and anonymization protocols, to ensure patient data privacy in accordance with regulations like HIPAA and GDPR.
The cV4's AI aims to improve diagnostic accuracy, reduce inter-operator variability, and decrease scan times compared to traditional systems. While AI can offer superior specificity and reduce false positives, physicians should consider its performance metrics against other AI systems based on specific clinical needs, as some studies show varied sensitivity compared to radiologists.
The cV4 system generally involves an upfront purchase cost for the hardware. There are often separate subscription models for ongoing AI software updates, access to advanced features, and technical support.
The cV4's AI, like other AI systems, may have limitations in interpreting highly atypical pathologies or in cases with significant image artifacts, and its performance can be dependent on the quality of image acquisition. Potential biases can arise if the AI systems are trained on non-representative datasets, necessitating continuous monitoring and physician judgment.
The cV4's AI is trained on extensive, diverse datasets of anonymized ultrasound images from various clinical settings. Its accuracy, sensitivity, and specificity metrics are typically detailed in clinical validation studies, which may show comparable or superior diagnostic performance to radiologists in specific applications, such as reducing false positives.
Yes, the cV4 system is designed for interoperability and supports standard healthcare communication protocols like DICOM and HL7. This enables seamless integration of its AI-generated reports, measurements, and images into most EMR systems, facilitating efficient data management and physician review.

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