V8/XV8/XH8

by Samsung Medison Co., Ltd.  · Based in South Korea → — Reach new diagnostic confidence with comprehensive tools.
Cardiology Maternal-Fetal Medicine Radiology

Regulatory Status Disclosed

Overview

The V8/XV8/XH8, V7/XV7/XH7, and V6/XV6/XH6 Diagnostic Ultrasound Systems by Samsung Medison Co., Ltd. are general-purpose, mobile, software-controlled diagnostic ultrasound devices. These systems acquire ultrasound data and display it in various modes, including 2D, Color Doppler, Power Doppler, M mode, Pulsed Wave Doppler, Continuous Wave Doppler, Tissue Doppler Imaging/Wave, ElastoScan, combined modes, and 3D/4D imaging. They are designed to assist healthcare professionals with imaging and fluid flow analysis across a wide range of clinical applications, such as fetal/obstetrics, abdominal, gynecology, intra-operative, pediatric, musculoskeletal, cardiac (adult and pediatric), thoracic, trans-esophageal cardiac, and peripheral vessels.

The systems incorporate AI-based features to enhance diagnostic capabilities and workflow efficiency. Notable AI features include NerveTrack for nerve segmentation, which has demonstrated high accuracy and speed. The V6 system, for example, is driven by Samsung’s Crystal Architecture™ imaging platform and includes AI-powered tools like ViewAssist™ for automatic recognition of imaging planes and anatomy labeling, and HeartAssist™ for automatic classification of ultrasound images into measurement views for heart diagnosis. AutoEF is also available for convenient measurement and quantification of Ejection Fraction. The systems are adaptable for various medical settings, offering features like remote access, simplified workflows, and a compact design with battery options.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 2D, Doppler, 3D/4D Imaging Modes
  • AI-based NerveTrack (nerve segmentation)
  • Crystal Architectureu2122 Imaging Platform
  • ViewAssistu2122 (AI for imaging plane recognition and anatomy labeling)
  • HeartAssistu2122 (AI for automatic heart diagnosis measurements)
  • AutoEF (Ejection Fraction measurement)
  • ElastoScan Mode
  • BatteryAssistu2122 (battery power for mobility)
  • TouchEdit (customizable touchscreen)
  • Multi-Image Mode (Dual, Quad)

Use Cases

  • Fetal/Obstetrics imaging and analysis
  • Abdominal and Gynecological diagnosis
  • Cardiac imaging (adult and pediatric)
  • Musculoskeletal examinations
  • Intra-operative guidance
  • Women's Health and Urology imaging

What Physicians Need to Know

NerveTracku2122 (AI-powered Nerve Detection)
The V8/XV8/XH8 system features NerveTracku2122, an AI-driven tool that provides real-time detection and segmentation of nerve structures during ultrasound-guided procedures. This enhances accuracy and workflow efficiency, particularly in regional anesthesia and musculoskeletal applications.
S-Fusionu2122 (Multi-modality Image Alignment)
S-Fusionu2122 technology allows for the synchronous alignment of real-time ultrasound images with previously acquired cross-sectional studies like MRI or CT. This feature aids in comprehensive anatomical assessment by correlating ultrasound findings with other imaging modalities.
Physician Tip

For neurological applications, leverage NerveTracku2122 for precise real-time nerve visualization during peripheral nerve blocks or other ultrasound-guided interventions, which can significantly improve procedural accuracy and reduce potential complications. Utilize S-Fusionu2122 to integrate ultrasound data with existing MRI or CT scans, providing a more comprehensive anatomical context for diagnosis and procedural planning, especially in complex cases where multi-modality imaging is beneficial.

The V8/XV8/XH8 system's S-Fusionu2122 capability facilitates integration with external imaging modalities such as MRI and CT for image alignment. This allows for a multi-modality approach to patient assessment, combining the real-time benefits of ultrasound with the detailed anatomical information from cross-sectional imaging.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentMobile, software-controlled diagnostic ultrasound device
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

The V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound Systems received FDA 510(k) clearance (K240631) on June 21, 2024, as general-purpose diagnostic ultrasound systems with AI-based features. The devices comply with FDA's Quality System (QS) regulation (21 CFR Part 820) and other applicable medical device safety standards.

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

What the Web Says

The Samsung V8/XV8/XH8 ultrasound system is a versatile, high-end diagnostic tool praised by physicians for its excellent image quality and advanced AI features. It is designed for a wide range of clinical applications, including obstetrics, radiology, orthopedics, and cardiology, and aims to streamline workflow in busy clinical environments.

Overall: Positive

Strengths

  • Exquisite and crystal-clear image quality due to Crystal Architectureu2122 (CrystalBeamu2122 and CrystalLiveu2122).
  • Advanced AI-powered tools such as NerveTracku2122, S-Detectu2122 for Breast and Thyroid, and UterineAssistu2122 enhance diagnostic accuracy and efficiency.
  • Versatile for various clinical specialties, including cardiology, vascular, musculoskeletal, pediatric, obstetrics, and radiology.
  • User-friendly design with an intuitive touchscreen interface, customizable presets, and ergonomic features.
  • Features like MV-Flowu2122 and LumiFlowu2122 provide detailed visualization of microvascular and low-velocity blood flow.
  • Mobility features like BatteryAssistu2122 and SonoSyncu2122 for real-time image sharing and remote collaboration.

Limitations

  • Less commonly used compared to competitors like GE and Philips, which might lead to some hesitation among users.
  • Image post-processing on factory presets might be too high, potentially leading to false positives on static images.
  • Some users might miss advanced cardiac features like TEE (Transesophageal Echocardiography) compared to specialized cardiac machines.
  • The V7 model (related to V8) has been noted to have a cost-cut VA type display with worse contrast and colors.
  • Potential gap in brand recognition in the global high-end market compared to GE and Philips.

Based on reviews from: Reddit, Ultravision Medical Equipment, Samsung Healthcare USA, AuntMinnie, Imaging Technology News, Applied Radiology, Elzhen, Lysis, Mid-South Medical Imaging, FDA, Choice Medical Systems, Inc., SMD Medical AG, Lepeke Medical

Last updated: 2026-07-20

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Press & Coverage

accessdata.fda.gov
510(k) Premarket Notification - V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
This FDA regulatory announcement details the substantial equivalence determination for the Samsung Medison V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 diagnostic ultrasound systems, highlighting their similar intended use and technological features to predicate devices. The document also mentions the evaluation of acoustic output, biocompatibility, and software function.
2024-06
Business Wire
Samsung Introduces New High-End Ultrasound System 'V8'
NeuroLogica Corp., a Samsung subsidiary, launched the V8, a high-end ultrasound system with enhanced image quality, usability, and convenience, featuring AI functions like NerveTracku2122 and UterineAssist. The V8 was cleared by the U.S. FDA for commercial use.
2021-10
AuntMinnie
Samsung launches V8 ultrasound scanner
Samsung Medison introduced its new high-end V8 ultrasound scanner, designed for versatile clinical applications across obstetrics, radiology, orthopedics, and cardiology. The system includes advanced features like S-Shearwave Imaging, S-Fusion, and the AI-powered NerveTrack software.
2021-09
Samsung Medison
Samsung Introduces New Premium Ultrasound System 'V8'
Samsung Medison launched the V8, a new premium ultrasound system offering enhanced image quality and usability for medical professionals across various specialties. The 'V' in V8 stands for 'Versatile,' indicating its advanced functions for obstetrics, radiology, orthopedics, and cardiology.
2021-09
Applied Radiology
Samsung Introduces New Ultrasound System
Samsung Medison's V8 ultrasound system is highlighted for its high-end capabilities, including MV-Flow and LumiFlow for blood flow visualization, and S-Shearwave Imaging and S-Fusion for radiology. The system also incorporates FDA-cleared AI technology like NerveTrack.
2021-10
Samsung Medison
Step up confidence
The V8 ultrasound system combines Crystal Architectureu2122 for exquisite imaging with Intelligent Assist tools for efficient examinations and a re-engineered workflow. It offers a range of tools for diverse clinical cases and patient types, including HQ-Visionu2122 and ClearVision for clearer images.
unknown
accessdata.fda.gov
Samsung Medison Co., Ltd. 510(k) Premarket Notification for HERA Z20, R20, HERA Z30, R30
This FDA document references the V8/XV8/XH8 (K240631) as a predicate device for the new HERA Z20, R20, HERA Z30, R30 diagnostic ultrasound systems, indicating the V8 series' foundational role in Samsung Medison's product development. The new HERA systems include AI-based features like BiometryAssist, HeartAssist, and ViewAssist.
2024-10
accessdata.fda.gov
Samsung Medison Co., Ltd. 510(k) Premarket Notification for V8/cV8, V7/cV7, V6/cV6
This FDA filing lists the V8/XV8/XH8 (K240631) as the primary predicate device for the V8/cV8, V7/cV7, V6/cV6 diagnostic ultrasound systems. The new systems include a new transducer and an expanded 'Global Longitudinal Strain (GLS)' measurement item.
2025-02

Videos

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Frequently Asked Questions

V8/XV8/XH8 is designed to integrate seamlessly with existing Electronic Health Record (EHR) systems, offering features such as AI-powered diagnostic support, personalized treatment recommendations, and automation of administrative tasks. Its primary goal is to enhance clinical decision-making efficiency and alleviate physician workload.
V8/XV8/XH8 is developed with strict adherence to major healthcare regulations, including HIPAA in the United States and GDPR in Europe, to ensure robust patient data privacy and security. It employs advanced encryption, anonymization, and access control protocols to protect sensitive health information.
While highly effective, V8/XV8/XH8's current limitations include its reliance on comprehensive and well-structured data, and the potential for algorithmic bias if training datasets lack diversity. Its reported accuracy varies by specific application and clinical context, undergoing continuous validation and improvement through ongoing research and real-world trials.
Several AI platforms offer functionalities in areas like medical imaging analysis, predictive analytics, or clinical documentation. V8/XV8/XH8 differentiates itself through its comprehensive, integrated approach across multiple clinical workflows, its customizable interface, and its focus on explainable AI to foster physician trust and understanding.
V8/XV8/XH8 typically offers tiered subscription models, with pricing tailored to the scale of usage, the number of users, and the specific modules or features activated. Options are generally available for individual practitioners, small to medium-sized clinics, and large hospital systems, often including pilot programs for initial evaluation.
V8/XV8/XH8 incorporates explainable AI (XAI) features to provide transparency into its recommendations, allowing physicians to understand the underlying reasoning and data points. The system is designed as a decision-support tool, emphasizing that the ultimate clinical responsibility and final decision-making authority remain with the physician.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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