V8 Diagnostic Ultrasound System

by Samsung Medison Co.  · Based in South Korea → — Elevating diagnostic confidence with versatile, high-end ultrasound imaging and intelligent AI-powered assistance.
Anesthesiology Maternal-Fetal Medicine Radiology

Contact for pricing (new units); used units range from $23,563 to $69,613.
Regulatory Status Disclosed

Overview

The V8 Diagnostic Ultrasound System by Samsung Medison Co. is a high-end, versatile ultrasound system designed to provide enhanced image quality, usability, and convenience for medical professionals across various specialties. It integrates advanced imaging technologies, such as Crystal Architecture™ (combining CrystalBeam™ beamforming and CrystalLive™ processing with S-Vue Transducer™ technology), to deliver superior image clarity, diagnostic accuracy, and workflow efficiency.

The system is equipped with a suite of Intelligent Assist tools, many of which leverage artificial intelligence (AI), to streamline examinations and support diagnostic confidence. Key AI functions include NerveTrack™ for real-time nerve location detection, and UterineAssist for detecting tissue changes and assisting with uterine measurements. Other intelligent features like MV-Flow™ and LumiFlow™ enhance the visualization of microvascular blood flow, while S-Shearwave Imaging™ provides information on tissue stiffness.

The V8 system is optimized for use in busy clinical environments, offering an ergonomic design with a 23.8″ LED monitor and a 14″ high-sensitivity touch panel for enhanced user convenience. It supports a wide range of clinical applications, making it a comprehensive diagnostic tool for diverse patient needs.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Crystal Architectureu2122 (CrystalBeamu2122, CrystalLiveu2122, S-Vue Transduceru2122) for superior image quality
  • IntelligentAssistu2122 tools for streamlined workflow
  • NerveTracku2122 AI for real-time nerve location detection
  • UterineAssist AI for detecting tissue changes and assisting with uterine measurements
  • MV-Flowu2122 for observing microvascular and low-velocity blood flow
  • LumiFlowu2122 for 3D visualization of blood flow
  • S-Shearwave Imagingu2122 for tissue stiffness information
  • S-Fusionu2122 for synchronous alignment of ultrasound with cross-sectional studies like MRI
  • 5D CNS+u2122 for simplified fetal brain assessment
  • SonoSyncu2122 for real-time image sharing across PC and mobile platforms

Use Cases

  • Diagnostic imaging in obstetrics and gynecology
  • Radiological assessments, including tissue stiffness analysis
  • Orthopedic and musculoskeletal disease diagnosis and nerve tracking
  • Cardiac adult and pediatric assessments
  • Abdominal, small organ, and peripheral vessel examinations
  • Pediatric imaging and neonatal cephalic studies

What Physicians Need to Know

Stroke Detection Capabilities
The V8 system features MV-Flowu2122 and LumiFlowu2122 for visualizing microvascular and slow blood flow, and providing three-dimensional visualization of blood flow, which are crucial for vascular imaging and detecting microcirculatory issues relevant to stroke assessment. S-Flowu2122 further aids in visualizing peripheral blood vessels. The system supports Adult Cephalic and Peripheral vessel applications.
Neurodegenerative Disease Screening Relevance
S-Shearwave Imagingu2122 provides information on tissue stiffness using ultrasonic transverse elasticity, which can be a relevant biomarker for assessing tissue changes associated with various diseases. The system is applicable for Adult Cephalic studies.
Large Vessel Occlusion Detection
The MV-Flowu2122 and LumiFlowu2122 features enhance the visualization of blood flow, including slow and microvascular flow, while S-Flowu2122 assists in visualizing peripheral blood vessels. These capabilities are directly relevant for identifying vascular issues, such as potential large vessel occlusions. It is indicated for Peripheral vessel applications.
Triage Prioritization Support
The V8 is designed with 'Intelligent Assist' tools and a re-engineered workflow to facilitate efficient and streamlined examinations, aiming to meet the demands of busy clinical environments and potentially aid in faster patient assessment.
Physician Tip

The Samsung V8 Diagnostic Ultrasound System is a versatile tool, offering enhanced image quality and AI-driven features for confident diagnoses across various specialties, including radiology and cardiology. Physicians can leverage S-Fusionu2122 for multi-modality comparison by aligning ultrasound images with MRI scans. The MV-Flowu2122 and LumiFlowu2122 technologies are particularly beneficial for detailed vascular assessments, while NerveTracku2122 offers real-time nerve tracking, primarily for musculoskeletal applications. Its ergonomic design and intuitive touchscreen interface contribute to an efficient workflow.

A key integration feature of the V8 system is S-Fusionu2122 technology, which allows for the synchronous alignment of ultrasound images with cross-sectional studies like MRI, enhancing diagnostic capabilities through multi-modality imaging. Additionally, SonoSyncu2122 enables real-time image sharing, fostering collaboration among healthcare providers. The system is designed to integrate seamlessly into clinical workflows, supporting efficient data management within busy hospital settings.

Details

Category Neurology AI, OB/GYN AI, Radiology & Imaging AI
Pricing Contact for pricing (new units); used units range from $23,563 to $69,613. — New units: Contact sales; Used units: $23,563 - $69,613 (Bimedis marketplace)
DeploymentOn-premise (physical medical device)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The V8 Diagnostic Ultrasound System received FDA 510(k) clearance (K220975) on February 13, 2023, expanding its AI-based NerveTrack™ and including BiometryAssist and ViewAssist.

Integrations
EHR Not specified
Specialties Anesthesiology, Maternal-Fetal Medicine, Radiology

What the Web Says

The Samsung V8 Diagnostic Ultrasound System is a high-end, versatile ultrasound machine designed for a wide range of clinical applications, including obstetrics, gynecology, cardiology, abdominal, pediatric, and musculoskeletal imaging. It features advanced imaging technologies like Crystal Architectureu2122 for enhanced clarity and penetration, and incorporates AI-powered tools such as NerveTrack, UterineAssist, BiometryAssist, ViewAssist, and HeartAssist to improve diagnostic efficiency and workflow. The system is mobile, software-controlled, and offers various 2D, 3D, 4D, and 5D imaging modes.

Overall: Positive

Strengths

  • Crystal-clear imaging across all probes and advanced imaging technologies like Crystal Architectureu2122 (CrystalBeamu2122, CrystalLiveu2122, S-Vue Single Crystal Transducersu2122) provide exceptional image clarity and penetration.
  • Versatile for a wide range of clinical applications, including fetal/obstetrics, abdominal, gynecology, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal/vaginal, musculoskeletal, urology, and cardiac.
  • AI-powered tools such as NerveTrack, UterineAssist, BiometryAssist, ViewAssist, and HeartAssist enhance diagnostic efficiency and assist with measurements and tissue change detection.
  • SonoSyncu2122 feature allows real-time remote collaboration and guidance, which is beneficial for training and second opinions.
  • Offers various 3D, 4D, and 5D technologies, including 5D CNS+u2122 for simplified fetal brain assessment.
  • User-friendly design and controls, making it easy to appreciate image quality and indications for each probe.

Limitations

  • No specific cons were identified in the provided search results.
  • Limited independent physician reviews were found outside of promotional materials.
  • No reviews from G2 or Capterra were found.
  • The provided information does not include details on pricing or long-term reliability.
  • While AI features are highlighted, the extent of their impact on overall workflow improvement is not detailed in independent reviews.
  • The system's complexity might require thorough training for optimal utilization of all advanced features.

Based on reviews from: accessdata.fda.gov, GlobalData, Scribd, ATX Vet Solutions (Dr. Christina Zhu), Innolitics, Ultravision Medical Equipment, BioSpace, Applied Radiology, device.report, Probo Medical

Last updated: 2026-07-19

Ratings & Reviews

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Clinical Value
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Press & Coverage

X-ray Interpreter (RadAI Slice)
V8 Diagnostic Ultrasound System | FDA Radiology AI Device
The V8 Diagnostic Ultrasound System by Samsung Medison is a mobile ultrasound device that captures real-time images and analyzes body fluids across various clinical applications. It incorporates AI-based features like NerveTrack and UterineAssist to enhance diagnostic accuracy and efficiency.
2021-09
Scribd (U.S. Food & Drug)
U.S. Food & Drug - 510(k) Premarket Notification (K250999)
The FDA determined that the V8 Diagnostic Ultrasound System and several other Samsung Medison systems are substantially equivalent to existing devices, allowing their marketing under the 510(k) premarket notification process. These Class II devices are intended for various medical imaging applications and must comply with general controls and additional regulations.
2025-07
X-ray Interpreter (RadAI Slice)
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | FDA Radiology AI Device
The V8 and V7 Diagnostic Ultrasound Systems received FDA approval in June 2022. These systems offer a wide range of clinical applications and incorporate AI-supported nerve detection (NerveTrack) to assist clinicians in real-time diagnoses.
2022-06
X-ray Interpreter (RadAI Slice)
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | FDA Radiology AI Device
In February 2023, the V8 and V7 Diagnostic Ultrasound Systems by Samsung Medison received FDA approval. These systems utilize various imaging modes and AI-based tools like NerveTrack, BiometryAssist, ViewAssist, and HeartAssist to improve diagnostic workflow and image analysis.
2023-02
X-ray Interpreter (RadAI Slice)
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | FDA Radiology AI Device
Samsung Medison's V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System received FDA approval in June 2024. This general-purpose system includes AI-based NerveTrack for nerve segmentation, enhancing diagnostic capabilities across numerous clinical applications.
2024-06
GlobalData
Ultrasound Systems Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies
Samsung Medison obtained an additional 510(K) clearance for the V8 Diagnostic Ultrasound System in October 2023, as reported in GlobalData's pipeline analysis. This indicates ongoing regulatory activity and product development for the system.
2024-02
accessdata.fda.gov
510(k) Premarket Notification (K243702)
The FDA reviewed Samsung Medison's 510(k) premarket notification for the V8 Diagnostic Ultrasound System, along with V7 and V6 systems, determining substantial equivalence to legally marketed predicate devices. The systems are intended for various clinical applications including fetal/obstetrics, abdominal, and cardiac imaging.
2025-02
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
Samsung Medison's V8 Diagnostic Ultrasound System was among the cardiology AI/ML SaMD 510(k) clearances in 2025, with a submission date of April 1, 2025, and clearance on July 18, 2025. This highlights the system's integration of artificial intelligence and machine learning in cardiology applications.
2026-01

Videos

Product demos, reviews, and walkthroughs for V8 Diagnostic Ultrasound System.

View all on YouTube

Frequently Asked Questions

The V8 Diagnostic Ultrasound System incorporates several AI-powered features, including NerveTracku2122 for real-time detection and location of nerves during live scanning, and UterineAssistu2122 which aids in detecting tissue changes and measuring the uterus. Additionally, it features 5D CNS+u2122 to simplify fetal brain assessment by automatically providing nine planes simultaneously with biometric measurements.
The V8 Diagnostic Ultrasound System, including its AI functions like NerveTracku2122, has received clearance from the U.S. Food and Drug Administration (FDA) for commercial use. Samsung, through its subsidiary Boston Imaging, maintains policies to ensure the security and privacy of identifiable health information, adhering to HIPAA compliance standards. This includes measures for data encryption and secure handling of electronic protected health information (ePHI).
While AI enhances ultrasound, general limitations include operator dependency and image variability, which can affect full automation and diagnostic accuracy. AI cannot compensate for a lack of data if a specific area of interest is not adequately scanned by the operator. Ethical considerations also exist regarding potential biases in AI systems if trained on non-representative datasets.
The V8 system features S-Fusionu2122 technology, which allows for synchronous alignment of ultrasound images with other cross-sectional studies like MRI, implying integration capabilities for comprehensive patient data review. For data management, adherence to HIPAA compliance is critical, requiring robust cybersecurity measures, data encryption, and secure handling of ePHI to protect patient confidentiality.
Physicians might consider other Samsung ultrasound systems such as the Hera W9, W10, or V7, which also incorporate intelligent assist solutions. Beyond Samsung, alternatives include AI ultrasound solutions from companies like See-Mode for enhanced reporting, Us2.ai for automated cardiac parameters, Clarius for portable AI-powered imaging, and Siemens Healthineers with their ACUSON Origin system.
The price range for the Samsung V8 Diagnostic Ultrasound System can vary, with reported figures between approximately $23,481 and $69,371. Its AI functionality, such as NerveTracku2122 and UterineAssistu2122, contributes significantly to its value by enhancing diagnostic confidence, improving workflow efficiency, and potentially reducing exam times, offering a more advanced and versatile solution compared to traditional non-AI systems.
While specific training modules for the V8's AI features are not detailed, AI-driven training tools in ultrasound generally provide consistent, on-demand instruction to help healthcare providers learn at their own pace. The V8's AI features are designed to enhance usability and convenience, aiming to streamline examinations and improve work efficiency by automating tasks like measurements and providing real-time guidance.

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