cV8 Diagnostic Ultrasound System

by Samsung Medison Co.  · Based in South Korea → — Elevating Diagnostic Confidence with Advanced Ultrasound and AI.
Neurology Obstetrics & Gynecology Radiology
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Regulatory Status Disclosed

Overview

The cV8 Diagnostic Ultrasound System by Samsung Medison Co. is a premium, general-purpose, mobile, and software-controlled diagnostic ultrasound system designed to provide enhanced image quality, usability, and convenience across various medical specialties. It leverages Samsung’s innovative Crystal Architecture™ (CrystalBeam™, CrystalLive™, and S-Vue Single Crystal Transducers™) to produce clear, uniform, and high-resolution images, aiding clinicians in making accurate diagnoses. The system integrates advanced AI-based diagnostic assistance functions, including NerveTrack™, UterineAssist™, BiometryAssist™, ViewAssist™, and HeartAssist™, to streamline workflows and improve diagnostic confidence. The cV8 is optimized for use in busy clinical environments, featuring an ergonomic design with a 23.8” LED monitor and a 14” high-sensitivity touch panel. It supports a wide range of imaging modes and offers robust data management capabilities, including DICOM 3.0 compatibility and cybersecurity features.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Crystal Architectureu2122 (CrystalBeamu2122, CrystalLiveu2122, S-Vue Single Crystal Transducersu2122) for superior image clarity and penetration
  • AI-based Intelligent Assist solutions: NerveTracku2122 (nerve detection), UterineAssistu2122 (uterus measurement), BiometryAssistu2122 (fetal growth), ViewAssistu2122 (fetal annotation), HeartAssistu2122 (fetal heart diagnosis)
  • MV-Flowu2122 and LumiFlowu2122 for detailed microvascular blood flow visualization
  • S-Shearwave Imagingu2122 for quantitative tissue stiffness assessment
  • S-Fusionu2122 technology for synchronous alignment of ultrasound with other imaging modalities like MRI
  • ShadowHDRu2122 for suppressing shadows and enhancing grayscale image clarity
  • EzExam+u2122 and EzPrepu2122 for streamlined examination protocols and workflow efficiency
  • Ergonomic design with 23.8u201d LED monitor and 14u201d high-sensitivity touch panel
  • DICOM 3.0 Compatible for seamless image and data management
  • Integrated cybersecurity features including Windows 10, Windows Defender, EMR/DICOM Secure Transmission (DICOM TLS), SSD Encryption (BitLocker), and Audit Trails

Use Cases

  • Comprehensive diagnostic imaging across various anatomical regions and patient populations
  • Detailed fetal and obstetric assessments, including growth and cardiac anomaly detection
  • Cardiovascular diagnostics for adult and pediatric patients, including advanced flow visualization and strain analysis
  • Radiology applications, such as tissue stiffness assessment and multi-modality image fusion
  • Musculoskeletal imaging with AI-assisted nerve tracking
  • Point-of-care diagnostics in hospitals, private practices, and clinics

What Physicians Need to Know

ECG/EKG Analysis Capability
The HeartAssistu2122 deep learning-based AI integrates with ECG for more accurate M-mode measurements, particularly in detecting End-Diastole (ED) and End-Systole (ES) at the QRS complex, especially beneficial in arrhythmia cases.
Echocardiography AI Features
Features include HeartAssistu2122 for automated view classification and cardiac measurements across B-mode, M-mode, and Doppler imaging, supporting 20 echocardiographic views with high accuracy (up to 98% for view classification, 95-100% for measurements). Strain+ provides quantitative assessment of global and segmental wall motion for the left ventricle, left atrium, and right ventricle. The StressEcho package offers wall motion scoring. MV-Flowu2122 and LumiFlowu2122 enhance visualization of microvascular and 3D blood flow. ViewAssistu2122 classifies ultrasound images to deliver key scanning views and provides anatomical annotations.
Cardiac CT/MRI Analysis
As an ultrasound system, the cV8 does not perform direct Cardiac CT/MRI analysis. However, it features S-Fusionu2122 technology, enabling synchronous alignment of ultrasound images with cross-sectional studies like MRI for comprehensive multi-modality assessment.
Arrhythmia Detection Accuracy
While not a standalone arrhythmia detection tool, the HeartAssistu2122 feature, when integrated with ECG, significantly improves the accuracy of M-mode measurements in patients with arrhythmias by correctly identifying cardiac cycle phases.
Heart Failure Risk Prediction
The system provides critical data for heart function assessment through features like Strain+ and StressEcho. While it contributes essential diagnostic information, there is no explicit integrated AI feature for direct heart failure risk prediction within the ultrasound system itself.
Coronary Artery Assessment
The cV8 offers advanced imaging capabilities such as S-Flowu2122 for visualizing peripheral blood vessels and MV-Flowu2122 for enhancing microvascular blood flow visualization, which are valuable for cardiac and vascular assessments.
Cardiac Monitoring Integration
The HeartAssistu2122 AI feature integrates with ECG signals for more precise cardiac measurements. Additionally, SonoSyncu2122 facilitates real-time ultrasound image sharing, allowing for remote collaboration and monitoring.
AHA/ACC Guideline Alignment
HeartAssistu2122 supports multi-cycle measurements, which addresses inter-beat variability and aligns with clinical guidelines for accurate cardiac assessment. The emphasis on ECG integration for accurate M-mode measurements also reflects adherence to best practices.
Physician Tip

Leverage HeartAssistu2122 for efficient and consistent echocardiographic measurements, especially with ECG integration to optimize accuracy in arrhythmia cases. Utilize Strain+ and StressEcho for comprehensive assessment of global and segmental heart function. Employ MV-Flowu2122 and LumiFlowu2122 for detailed visualization of microvascular and 3D blood flow, aiding in vascular and cardiac evaluations. Remember that while the cV8 provides critical AI-enhanced data, clinical interpretation and correlation with other patient information remain essential for definitive diagnosis and risk stratification.

The cV8 system integrates with ECG for enhanced AI-driven measurements via HeartAssistu2122. SonoSyncu2122 enables real-time image sharing for remote collaboration and second opinions. Its S-Fusionu2122 technology allows for synchronous alignment of ultrasound images with cross-sectional studies like MRI, facilitating a comprehensive multi-modality approach to patient care.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact vendor — N/A
DeploymentOn-premise (hardware)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The cV8 Diagnostic Ultrasound System (along with V8, V7, cV7, V6, cV6, V5, cV5, V4, cV4) received 510(k) premarket notification clearance (K250999) from the FDA. It is classified as a Class II device.
Integrations
EHR Not specified
Specialties Neurology, Obstetrics & Gynecology, Radiology

What the Web Says

The Samsung cV8 Diagnostic Ultrasound System is a versatile, mobile ultrasound solution designed for a broad range of medical specialties, including obstetrics, gynecology, radiology, neurology, and cardiology. It emphasizes user-friendliness with an intuitive interface and streamlined examination protocols, aiming to reduce the learning curve for medical professionals. The system incorporates AI-based intelligent assist solutions and Crystal Architectureu2122 for superior image quality and enhanced workflow efficiency.

Overall: Positive

Strengths

  • Superior image quality and penetration due to Crystal Architectureu2122 (CrystalBeamu2122, CrystalLiveu2122, S-Vue Single Crystal Transducersu2122).
  • Versatile for a wide range of medical specialties including obstetrics, gynecology, radiology, orthopedics, and cardiology.
  • User-friendly interface and streamlined examination protocols (EzExam+, EzPrep) contribute to ease of use and a reduced learning curve.
  • AI-based intelligent assist solutions like NerveTracku2122 and UterineAssistu2122 enhance workflow efficiency and diagnostic confidence.
  • Mobile and ergonomic design, with a dedicated cardiovascular control panel.
  • Explicitly states BAA and HIPAA compliance, indicating readiness for enterprise deployment and data security.

Limitations

  • Primarily focused on essential 2D and Doppler imaging, and may have fewer advanced AI automation and workflow features compared to more premium, specialized cardiac systems like the GE Vivid T9.
  • While versatile, some highly specialized systems might offer more in-depth features for specific applications (e.g., advanced cardiac CT data post-processing in CardIQ Suite).
  • No specific EHR integrations are detailed, though other platforms often offer bi-directional EHR integrations.
  • No videos found for demos, reviews, and walkthroughs featuring the cV8 Diagnostic Ultrasound System in some searches.
  • Some general Reddit discussions about handheld ultrasounds mention issues with mandatory cloud services for saving images and potential defects in early ultrasounds from other brands, though these are not directly attributed to the cV8.
  • Compared to some competitors, it might be considered less advanced for comprehensive cardiac diagnostics if a practice requires sophisticated diagnostic capabilities beyond basic imaging.

Based on reviews from: Medical AI Tools for Physicians (CardIQ Suite vs cV8 Diagnostic Ultrasound System), Medical AI Tools for Physicians (Autoplaque vs cV8 Diagnostic Ultrasound System), Samsung CV8 vs GE Vivid T9 Ultrasound | PDF - Scribd, Reddit - Best handheld ultrasound for hospital medicine?, accessdata.fda.gov (Samsung Medison Co., Ltd. Yujin Kim Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REP), cV Ultrasound Systems - for cardiovascular - image, accessdata.fda.gov (Samsung Medison Co., Ltd. Yujin Kim Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REP), Samsung Introduces New High-End V8 System, Best Cardiovascular Ultrasound Machines in 2023, A Buyer's Guide | Probo Medical, Reddit - Best portable ultrasound machines., MedGrade - Samsung Galaxy Watch 8 Review: Medically-Cleared Sleep Apnea Detection and ECG Monitoring, Reddit - Best handheld ultrasound machine in the market now? : r/anesthesiology, Reddit - Best handheld ultrasound machine in the market now? : r/emergencymedicine, Samsung cV Ultrasound Systems Overview | PDF | Heart | Diastole, TrustRadius - Capterra Reviews & Ratings 2026, Samsung Introduces New Premium Ultrasound System 'V8', Trustpilot - Read Customer Service Reviews of www.capterra.com, Capterra - Page 2 | Best Medical Imaging Software 2026, Mindray - MX8 Cardiovascular Ultrasound System, YouTube - Samsung CEUS+ Cases Review by Dirk Andru00c3u00a9 Clevert M D HD, Reddit - Ultrasound Purchase Advice, YouTube - Mindray M8 Elite Portable Ultrasound Review, Reddit - Thoughts on healthcare IT, YouTube - Samsung Galaxy Watch 8 Vascular Load Review and Accuracy, YouTube - GE HealthCare Vscan Air Handheld Ultrasound Review, BB Imaging - Sonographer Review of Ultrasound Equipment, PMC - Comparison of 6 handheld ultrasound devices by point-of-care ultrasound experts: a cross-sectional study

Last updated: 2026-07-20

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Press & Coverage

FDA.report
cV8 Diagnostic Ultrasound System cV8 GUDID Device - FDA.report
This regulatory filing details the cV8 Diagnostic Ultrasound System as a stationary or mobile assembly of devices for collecting, displaying, and analyzing ultrasound images across various procedures. It includes a data processing unit with integrated software and a monitor, supporting a wide range of transducers and application software packages.
2025-02
Constat
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (K223387) - Constat
This article discusses the FDA clearance history for the V8 and cV8 Diagnostic Ultrasound Systems, noting multiple 510(k) clearances from Samsung Medison Co., Ltd. It highlights the system's AI-based features like NerveTrack, BiometryAssist, and ViewAssist, which aid in nerve detection, measurement, and view recognition.
2026-07
FDA
K250999 - 510(k) Premarket Notification - FDA
This FDA premarket notification confirms the substantial equivalence of the V8 Diagnostic Ultrasound System, including the cV8, to existing devices, allowing Samsung Medison to market it. The document outlines the device's classification as Class II and its intended use for various medical imaging applications.
2025-07
X-ray Interpreter (RadAI Slice)
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | FDA Radiology AI Device - X-ray Interpreter
This entry details the FDA approval of the V8 and V7 Diagnostic Ultrasound Systems by Samsung Medison, highlighting their advanced AI-based tools such as NerveTrack, BiometryAssist, ViewAssist, and HeartAssist for various clinical applications. The systems are designed to improve diagnosis and workflow efficiency in medical imaging.
2023-02
X-ray Interpreter (RadAI Slice)
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | FDA Radiology AI Device - X-ray Interpreter
This article describes the FDA approval of the V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System, a general-purpose system with AI-based NerveTrack for nerve segmentation. It supports multiple imaging and Doppler modes for various clinical applications.
2024-06
X-ray Interpreter (RadAI Slice)
V8 Diagnostic Ultrasound System | FDA Radiology AI Device - X-ray Interpreter
This FDA approval record for the V8 Diagnostic Ultrasound System by Samsung Medison highlights its general-purpose, mobile design and AI-based features like NerveTrack and UterineAssist. The system aims to assist clinicians in diagnosis and measurement across various clinical applications.
2021-09
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
This review of 2025 cardiology AI/ML SaMD 510(k) clearances includes the Samsung Medison V8 Diagnostic Ultrasound System, cV8 Diagnostic Ultrasound System, and other related models. It lists the FDA clearance date as July 18, 2025.
2026-01
Physician AI Tools
cV8 Diagnostic Ultrasound System vs OPTIS Mobile Next Imaging - Physician Ai Tools
This comparison highlights the cV8 Diagnostic Ultrasound System as a mobile, real-time imaging solution with advanced AI assistance across multiple specialties, emphasizing its HIPAA compliance and BAA availability. It notes the system's innovative integration of AI directly into the hardware with technologies like Crystal Architectureu2122.
unknown

Videos

Product demos, reviews, and walkthroughs for cV8 Diagnostic Ultrasound System.

View all on YouTube

Frequently Asked Questions

The cV8's AI assists by automating measurements, providing real-time image optimization, and highlighting regions of interest, potentially reducing scan times and improving consistency in diagnoses. It aims to augment, not replace, the physician's expertise by streamlining repetitive tasks and offering decision support.
The cV8 system's AI algorithms are cleared by relevant regulatory bodies (e.g., FDA/CE Mark) for their intended diagnostic support functions. It adheres to strict data privacy regulations like HIPAA/GDPR, employing encryption and anonymization protocols to protect patient information throughout the AI processing pipeline.
The AI's performance can be influenced by image quality, patient-specific anatomies, and rare pathologies not well-represented in its training data. It serves as a decision support tool, and physicians must exercise their clinical judgment, especially in ambiguous or complex cases, as it may not detect all anomalies or could generate false positives.
The cV8 distinguishes itself through its specific AI algorithms designed for advanced image analysis and quantitative assessment, offering a higher degree of automation and consistency compared to traditional systems. While other AI systems exist, the cV8 focuses on integrating AI seamlessly into the entire scanning workflow, from acquisition to reporting.
The cV8 system typically involves an initial capital expenditure for the hardware, with the AI features often bundled or offered as an annual software license or subscription. This model ensures continuous updates and access to new AI functionalities and support, rather than a per-use fee for individual AI analyses.
The cV8 system is designed for secure integration with existing PACS and EMR systems, utilizing standard protocols for data transfer. AI processing can occur on-device or securely in a compliant cloud environment, with robust encryption and access controls in place to maintain data integrity and confidentiality throughout the workflow.
Comprehensive training programs are offered, including on-site sessions, online modules, and clinical application specialist support, to ensure users can maximize the cV8's AI capabilities. Ongoing technical support and educational resources are also available to help integrate the system seamlessly into clinical practice and address any queries.

Compare cV8 Diagnostic Ultrasound System

VS
TruPlan vs cV8 Diagnostic Ultrasound System
Cardiology AI Adjacent · 65/100
TruPlan is a CT imaging software specifically designed for pre- and post-procedural planning of Left Atrial Appendage Closure (LAAC) procedures, offering advanced visualization and measurement tools for CT…
VS
cV8 Diagnostic Ultrasound System vs EchoNext
Cardiology AI Adjacent · 65/100
These tools are adjacent in their focus on cardiac diagnostics but serve different primary functions. Tool A, the cV8 Diagnostic Ultrasound System, is a hardware-based ultrasound system offering…
VS
CardIQ Suite vs cV8 Diagnostic Ultrasound System
Cardiology AI Adjacent · 65/100
While both tools leverage AI in cardiology and radiology, they are not direct competitors. CardIQ Suite is a software application focused on post-processing cardiac CT data for diagnosis…
VS
cV8 Diagnostic Ultrasound System vs AHI System
Cardiology AI Adjacent · 65/100
Tool A, the Samsung Medison cV8, is a diagnostic ultrasound system that uses AI to enhance image quality and assist with measurements and nerve detection across various specialties,…

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