V8/H8 Diagnostic Ultrasound System

by Samsung Medison Co., Ltd.  · Based in South Korea → — Elevate Diagnostic Confidence with Advanced AI Ultrasound.
Neurology Obstetrics & Gynecology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The Samsung V8/H8 Diagnostic Ultrasound System is a premium, general-purpose, mobile, software-controlled diagnostic ultrasound system designed to provide enhanced image quality, usability, and convenience for healthcare professionals. Powered by Samsung’s Crystal Architecture™ imaging engine, it delivers crystal-clear imaging quality and exceptional resolution across a wide range of clinical applications. The system integrates intelligent assist tools and re-engineered workflows to streamline examinations and enhance diagnostic confidence in busy clinical environments. Key AI-based features include NerveTrack™ for real-time nerve detection and segmentation during live scanning, and UterineAssist™ for automated uterine measurements to aid in detecting abnormalities. The V8/H8 supports various imaging modes such as 2D, Color Doppler, Power Doppler, M mode, Pulsed Wave Doppler, Continuous Wave Doppler, Tissue Doppler Imaging, ElastoScan, Multi-Image, and 3D/4D modes. It is intended for use by appropriately trained healthcare professionals in hospitals, private practices, clinics, and similar care environments for clinical diagnosis of patients and fluid flow analysis.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Crystal Architectureu2122 imaging engine for superior image quality
  • AI-based NerveTracku2122 for real-time nerve detection and segmentation
  • AI-powered UterineAssistu2122 for automated uterine measurements
  • Comprehensive imaging modes (2D, Color Doppler, Power Doppler, M mode, PW/CW Doppler, TDI, TDW, ElastoScan, Multi-Image, 3D/4D)
  • SonoSyncu2122 for remote diagnostic image viewing and review
  • ShadowHDRu2122 for enhancing hidden structures in shadowed regions
  • MV-Flowu2122 for visualizing microvascular perfusion
  • LumiFlowu2122 for 3D-like visualization of blood flow
  • S-Shearwave Imagingu2122 for non-invasive tissue stiffness assessment
  • Ergonomic design with intuitive touchscreen and workflow enhancements (EzCompareu2122, EzExamu2122)

Use Cases

  • Fetal and obstetrics imaging and assessment
  • Abdominal and gynecological examinations
  • Cardiac imaging (adult and pediatric)
  • Musculoskeletal imaging and nerve identification procedures
  • Urology and small organ imaging
  • Vascular imaging and fluid flow analysis

What Physicians Need to Know

Fetal Monitoring AI
The V8/H8 system incorporates 'Intelligent Assist' solutions, including 'Biometry Solution' for automated fetal growth assessment (head, abdomen, lower extremities) and 'Fetal Heart Solution' for comprehensive fetal heart anomaly assessment, recognizing views, annotating, and measuring structures. 'BiometryAssistu2122' automates fetal biometry measurements for quicker, consistent prenatal assessments. 'HeartAssistu2122' categorizes and provides measurement results for fetal heart diagnosis. '5D CNS+u2122' simplifies fetal brain assessment by automatically providing nine essential planes and biometric measurements. '5D Heart Coloru2122' identifies 9 standard planes of the heart using fetal STIC data, offering crucial information for fetal heart development. 'Live ViewAssistu2122' automatically extracts ultrasound cross-sectional images, provides automated annotations and measurement results for key parameters throughout pregnancy, and includes 'QualityCheck' for evaluating image quality during fetal diagnosis.
Ultrasound Image Analysis
The system's 'Intelligent Assist' solutions streamline women's health examinations through automated measurements, annotations, and intuitive controls. 'ViewAssistu2122' utilizes deep learning to automatically classify ultrasound images and annotate anatomical structures. 'Crystal Architectureu2122' (combining CrystalBeamu2122 beamforming and CrystalLiveu2122 processing with S-Vue Transduceru2122) delivers superior image quality, enhanced 2D processing, realistic 3D rendering, and optimized color signal processing. 'ShadowHDRu2122' enhances image clarity by suppressing posterior shadows, revealing hidden structures in areas like the fetal head or spine. 'MV-Flowu2122' visualizes microcirculatory and slow blood flow, serving as an alternative to power Doppler, while 'LumiFlowu2122' provides three-dimensional visualization of blood flow. 'ClearVision' improves 2D image quality by reducing noise and halo artifacts.
Pregnancy Risk Assessment
The V8/H8 system includes an 'Ophthalmic Artery feature' to detect systemic vasoconstriction in early stages, a key indicator for pre-eclampsia. 'HeartAssistu2122' supports maternal health by real-time monitoring of cardiovascular conditions during pregnancy. The system is designed to facilitate the examination of high-risk pregnancies and the early diagnosis of abnormal fetal conditions.
Maternal Health Monitoring
'UterineAssistu2122' uses AI to automatically measure the size and shape of the uterus, aiding in the early detection of issues such as fibroids or other abnormalities. 'PelvicAssistu2122' automatically analyzes multiple pelvic regions and measures the levator hiatus area, providing a 3D image. 'Fibroid 2D' simplifies reporting for uterine fibroids based on FIGO guidelines, and 'IDEA' and 'IETA' support scan procedures and reporting for endometriosis and endometrial tumor evaluation, respectively.
IVF Support Tools
'5D Follicleu2122' identifies and measures multiple ovarian follicles in one scan for rapid assessment during controlled ovarian stimulation. '2D Follicleu2122' automatically identifies, counts, and measures the size of follicles in 2D images. The system supports HyCoSy / HyFoSy in 3D/4D for effective examination of fallopian tube patency and uterine/endometrial morphology.
Prenatal Testing Integration
'5D CNS+' provides biometric measurements for fetal brain assessment. 'BiometryAssistu2122' automates fetal biometry measurements. 'ViewAssistu2122' and 'BiometryAssistu2122' extend automated measurement and annotation of fetal growth indicators to the first trimester, aligning with revised ISUOG guidelines.
Labor & Delivery Support
'LaborAssistu2122' helps clinicians assess labor progress by automatically measuring the Angle of Progress (AoP) and fetal head direction, aiding in timely delivery decisions and effective communication with the mother.
Physician Tip

Leverage the V8/H8's 'Intelligent Assist' features to significantly enhance workflow efficiency and diagnostic accuracy, particularly in fetal biometry, cardiac assessment, and uterine evaluations. The automated measurements and annotations can reduce repetitive tasks, allowing more focused attention on complex cases and patient interaction. Utilize advanced imaging technologies like 'ShadowHDRu2122' and 'MV-Flowu2122' for clearer visualization of subtle anomalies and microvascular structures. The specialized tools for high-risk pregnancy assessment and fertility treatments can provide critical insights for timely intervention and personalized care. Integrating these AI tools into routine practice can streamline examinations, improve consistency, and boost confidence in diagnostic outcomes.

The V8/H8 system features 'SonoSyncu2122' for real-time image sharing across PC and mobile platforms, facilitating seamless communication, care guidance, training, and consultation among healthcare professionals. This capability suggests robust potential for integration with existing hospital information systems, Picture Archiving and Communication Systems (PACS), and Electronic Medical Record (EMR) systems, enabling a connected and collaborative healthcare environment. Samsung Medison's commitment to integrating IT, image processing, semiconductor, and communication technologies into its medical devices further supports comprehensive data flow and interoperability.

Details

Category OB/GYN AI, Radiology & Imaging AI
Pricing Contact for pricing — N/A
DeploymentOn-premise (physical ultrasound system)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The V8/H8 Diagnostic Ultrasound System, along with V7/H7 and V6/H6 systems, received 510(k) clearance (K231772) from the U.S. Food and Drug Administration (FDA) on October 3, 2023, for diagnostic ultrasound imaging and fluid flow analysis across a wide range of clinical applications.

Integrations
EHR Not specified
Specialties Neurology, Obstetrics & Gynecology, Radiology

What the Web Says

The Samsung V8/H8 Diagnostic Ultrasound System is a high-end, versatile ultrasound machine designed for a wide range of clinical applications, including obstetrics, radiology, orthopedics, and cardiology. It features advanced imaging technologies and AI-powered tools aimed at enhancing image quality, usability, and workflow efficiency. Physicians have generally expressed positive opinions, particularly regarding its image clarity and AI features, though some note its less common usage compared to other major brands.

Overall: Positive

Strengths

  • Enhanced image quality and penetration with Crystal Architecture.
  • AI-powered features like NerveTrack and UterineAssist for improved detection and measurement.
  • Versatile for use across various departments (OB/GYN, radiology, orthopedics, cardiology).
  • Ergonomic design and user-friendly features like a tilting touch screen and customizable buttons.
  • Good color pickup.
  • Remote access and collaboration capabilities (e.g., SonoSync for veterinary version).

Limitations

  • Less commonly used compared to established brands like GE/Philips, potentially leading to a learning curve or concerns about long-term support.
  • May lack some advanced cardiac features and TEE capabilities found in specialized cardiac machines.

Based on reviews from: Reddit, Applied Radiology, AuntMinnie, Samsung Medison, FDA.report, accessdata.fda.gov, Radiology AI Tools Directory, ATX Vet Solutions

Last updated: 2026-07-19

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Press & Coverage

FDA
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System - FDA 510(k) Premarket Notification
The FDA issued a 510(k) premarket notification for the Samsung Medison V8/H8, V7/H7, and V6/H6 Diagnostic Ultrasound Systems, indicating they are substantially equivalent to predicate devices for various clinical applications. The document details the intended use, device description, and non-clinical testing, including acoustic output and software function.
2023-10
X-ray Interpreter
Radiology AI Companies - X-ray Interpreter (V8/H8 Diagnostic Ultrasound System)
This article highlights the Samsung V8/H8 Diagnostic Ultrasound System as an advanced ultrasound machine with AI-based features like NerveTrack for nerve segmentation, supporting a wide range of clinical applications. It notes the FDA release date of October 3, 2023, for the V8/H8, V7/H7, and V6/H6 systems.
2023-10
FDA.report
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound ... - FDA.report
This entry confirms the FDA clearance for the V8/H8 Diagnostic Ultrasound System, along with the V7/H7 and V6/H6 systems, by Samsung Medison Co., Ltd. The clearance date is listed as October 3, 2023.
2023-10
FDA.report
LA2-16S USP-L02GF3A/WR GUDID Device - FDA.report
This FDA.report entry provides details on a specific transducer (LA2-16S USP-L02GF3A/WR) associated with the V8/H8 Diagnostic Ultrasound System, manufactured by Samsung Medison Co., Ltd. It confirms the primary DI and links it to the K231772 FDA clearance.
2023-10
Radiology AI Tools Directory
Ultrasound radiology AI tools | FDA-cleared directory
The V8/H8 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is listed in an FDA-cleared directory of ultrasound radiology AI tools. Its decision date for clearance is October 3, 2023, and it is categorized under image analysis/processing.
2023-10
Radiology AI Tools Directory
Search FDA-cleared listings - Radiology AI Tools Directory
This directory entry confirms the FDA clearance of the V8/H8 Diagnostic Ultrasound System from Samsung Medison Co., Ltd. The system, cleared on October 3, 2023, is noted for its image analysis/processing capabilities within ultrasound workflow.
2023-10

Videos

Product demos, reviews, and walkthroughs for V8/H8 Diagnostic Ultrasound System.

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Frequently Asked Questions

The V8 system incorporates AI features like NerveTracku2122 for real-time nerve detection during live scanning and UterineAssistu2122 for automated uterine measurements, which can enhance diagnostic accuracy and streamline workflow. Additionally, AI-powered S-Detectu2122 for Breast and Thyroid assists in standardizing lesion analysis and reporting, potentially improving diagnostic consistency and reducing examination time.
The V8 system, including its AI functions like NerveTracku2122 and UterineAssistu2122, has received FDA clearance for commercial use in the USA. While specific CE Mark details for the V8/H8's AI features aren't explicitly stated in the search results, medical AI devices generally undergo rigorous regulatory review. Patient data privacy is typically ensured through secure system architecture, encryption protocols, and adherence to standards like HIPAA, processing data locally or with secure, anonymized cloud solutions to mitigate re-identification risks.
The V8/H8's AI capabilities, such as NerveTracku2122 for nerve detection and UterineAssistu2122 for uterine measurements, offer specialized assistance in certain clinical areas. Other high-end systems may offer different AI strengths, such as advanced cardiac quantification (e.g., HeartAssistu2122 on other Samsung systems) or specialized elastography analysis, requiring physicians to compare specific features based on their clinical needs.
The search results do not provide specific pricing models for the V8/H8's AI features. Generally, AI features in high-end ultrasound systems are either integrated into the initial system purchase or offered as optional software packages. Future advanced AI functionalities or upgrades may involve additional licensing fees or subscription models, which would need to be clarified directly with the vendor.
While beneficial, AI algorithms, including those in the V8/H8, may have limitations such as potential reduced accuracy with atypical anatomies or poor image quality, and can carry inherent biases from their training data. Physician oversight is always critical, as the AI serves as an assistive tool, and the final diagnostic interpretation and clinical decision-making remain the responsibility of the clinician.
The V8/H8's AI-generated data, including automated measurements and reports, is designed for seamless integration with existing PACS and EHR systems through DICOM and other industry-standard protocols. This facilitates efficient data transfer and archiving. Minimal additional IT infrastructure is typically required beyond standard network connectivity, though specific integration needs should be discussed with the vendor.
Comprehensive training programs are typically offered by the vendor for the V8/H8 system, covering the operation and clinical application of its AI features like NerveTracku2122 and UterineAssistu2122 for both physicians and sonographers. Ongoing technical support and educational resources are also usually available to ensure optimal and safe utilization.

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