V6 Diagnostic Ultrasound System

by Samsung Medison Co.  · Based in South Korea → — Inspiring everyday efficiency.
Obstetrics & Gynecology Radiology Urology
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Regulatory Status Disclosed

Overview

The Samsung V6 Diagnostic Ultrasound System is a versatile and efficient medical imaging solution designed to meet the daily clinical demands across various medical fields. Powered by Samsung’s core imaging platform, Crystal Architecture™, the V6 delivers exceptional 2D, 3D, and color image quality, ensuring clear and accurate image acquisition for confident diagnoses.

The system integrates advanced artificial intelligence (AI) and Deep Learning technologies to enhance workflow efficiency and diagnostic accuracy. Key AI-powered features include ViewAssist™, which automatically recognizes imaging planes and labels anatomy; BiometryAssist™, a semi-automated tool for one-click fetal growth measurements; and UterineAssist™, an AI technology for automatic measurement of the uterus to assist in detecting abnormalities.

Beyond women’s health, the V6 offers specialized AI tools like NerveTrack™ for real-time nerve area detection in musculoskeletal imaging and HeartAssist™ for automatic classification of heart diagnosis measurement views in cardiovascular applications. Its compact and powerful design, often with a battery option, allows for portability and adaptability across diverse medical environments, from clinics to mobile units.

The V6 also facilitates streamlined workflows with features like QuickPreset for common transducer and preset combinations, and TouchEdit for customizable touchscreen functions. For enhanced communication and patient engagement, it includes SonoSync™ for real-time image sharing between doctors and sonographers, and Mobile Export (HelloMom™) for secure transfer of fetal images to patient smartphones via QR code.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Crystal Architectureu2122 imaging platform
  • ViewAssistu2122 (AI-powered imaging plane recognition and anatomy labeling)
  • BiometryAssistu2122 (Deep Learning-based fetal growth measurements)
  • UterineAssistu2122 (AI-powered uterus measurement for abnormality detection)
  • miniER7 Endocavity Transducer (180u00b0 field of view, patient comfort)
  • SonoSyncu2122 (Real-time image sharing for care guide and training)
  • Mobile Export / HelloMomu2122 (Secure fetal image transfer to smartphones)
  • NerveTracku2122 (Deep Learning-based nerve area detection for MSK)
  • HeartAssistu2122 (Deep Learning-based heart diagnosis measurement views)
  • Portable design with battery option

Use Cases

  • Fetal growth and development monitoring
  • Detection of uterine and gynecological abnormalities
  • Assessment of ovarian follicles for fertility treatments
  • Musculoskeletal nerve tracking and tissue stiffness assessment
  • General abdominal and vascular diagnostic imaging
  • Cardiovascular assessment and diagnosis

What Physicians Need to Know

Fetal Monitoring AI
Features BiometryAssistu2122 for semi-automated, one-click fetal growth measurements, enhancing consistency and reducing keystrokes, with capabilities extending to first-trimester measurements and fetal weight estimation up to 48 hours before delivery. ViewAssistu2122 automatically recognizes imaging planes and labels anatomy to streamline documentation and workflow. HeartAssistu2122 categorizes and provides measurement results for fetal heart diagnosis. The system also supports advanced fetal brain examination with 5D CNS+ for automatic provision of essential cross-sections and measurements.
Ultrasound Image Analysis
Powered by Crystal Architectureu2122, the V6 offers exceptional 2D, 3D, and color image quality with advanced automated tools. AI features like ViewAssistu2122 automatically recognize imaging planes and label anatomy. BiometryAssistu2122 and UterineAssistu2122 provide semi-automated fetal growth and uterine size/shape measurements, respectively, aiding in abnormality detection. Image enhancement technologies include ClearVision for noise reduction, HQ-Vision for anatomical structure visualization, and ShadowHDR for enhancing hidden structures. MV-Flowu2122 visualizes slow flow in microvascular vessels. S-Detectu2122 is available for breast and thyroid lesion analysis.
Pregnancy Risk Assessment
Supports first-trimester ultrasound for maternal-fetal risk assessment, including detection of aneuploidies, congenital heart defects, and spina bifida. BiometryAssistu2122 contributes to consistent fetal growth measurements crucial for risk evaluation.
Maternal Health Monitoring
UterineAssistu2122 automatically measures uterine size and shape, assisting in detecting uterine-related abnormalities. The expanded HeartAssistu2122 supports real-time monitoring of cardiovascular conditions during pregnancy. The miniER7 Endocavity Transducer is designed for patient comfort, potentially minimizing pain during pelvic examinations.
IVF Support Tools
Includes 5D Follicleu2122 for identifying and measuring multiple ovarian follicles in one scan, and 2D Auto Follicle for automatic identification, counting, and measurement of follicles from 2D images, aiding in folliculogenesis dynamics and cycle monitoring. UterineAssistu2122 and Uterine Contour assist in assessing uterine anatomy and identifying malformations, crucial for fertility treatments. The system is compatible with Cycle Clarity's AI-based software platform, making it suitable for reproductive endocrinology and infertility settings.
Prenatal Testing Integration
The V6 facilitates comprehensive first-trimester ultrasound scans, which are critical for maternal-fetal risk assessment and can complement non-invasive prenatal testing (NIPT) by providing detailed morphological and biometric data.
Labor & Delivery Support
Features LaborAssistu2122 to provide information on the progress of labor by automatically measuring the angle of progression and fetal head direction, aiding in delivery decisions.
Physician Tip

Leverage the V6's AI-powered tools like BiometryAssistu2122 and UterineAssistu2122 to significantly enhance workflow efficiency, ensure consistent measurements, and improve diagnostic confidence in fetal assessment and gynecological examinations. Utilize 5D Follicleu2122 and 2D Auto Follicle for streamlined fertility monitoring. The system's portability and user-friendly interface, including customizable touchscreens, allow for flexible deployment and optimized workflows across various clinical settings.

The V6 Diagnostic Ultrasound System is compatible with Cycle Clarity's AI-based software platform, making it well-suited for reproductive endocrinology and infertility practices. Additionally, SonoSyncu2122 enables real-time image sharing for enhanced communication and training between doctors and sonographers, facilitating collaborative care and remote support.

Details

Category OB/GYN AI, Radiology & Imaging AI
Pricing Contact for pricing
  • Pricing for the Samsung V6 Diagnostic Ultrasound System is not publicly available and typically varies based on configuration, transducers, and regional distribution
  • Contact Samsung Medison or a local sales representative for a quote
DeploymentOn-premise (physical hardware device)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Samsung V6 Diagnostic Ultrasound System has received FDA clearance under 510(k) Premarket Notification K250999, which was cleared on June 21, 2024.
Integrations
EHR Not specified
Specialties Obstetrics & Gynecology, Radiology, Urology

What the Web Says

The Samsung V6 Diagnostic Ultrasound System is a recently launched (November 2023) device designed to enhance efficiency and diagnostic accuracy, particularly in women's health, urology, and musculoskeletal imaging. It is powered by Samsung's Crystal Architectureu2122 imaging platform, offering exceptional 2D and color image quality. The system incorporates advanced automated features and AI-powered tools to streamline workflows and improve patient care.

Overall: Positive

Strengths

  • Exceptional 2D and color image quality for accurate diagnosis, powered by Crystal Architectureu2122.
  • Advanced automated features and AI-powered tools like BiometryAssistu2122 and UterineAssistu2122 reduce scan time and improve consistency.
  • Designed for patient comfort, especially with the miniER7 Endocavity Transducer, which has a smaller design and wide field of view.
  • Portable with battery capability, making it adaptable for various medical environments including outpatient clinics and mobile units.
  • User-friendly interface with customizable TouchEdit touchscreen for optimized workflows.
  • Features like ShadowHDR, MV-Flowu2122, and LumiFlowu2122 enhance visualization of hidden structures, slow blood flow, and complex vascular structures.

Limitations

  • No specific cons were identified in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • Some general discussions on Reddit about early pregnancy ultrasounds with handheld devices suggest that transvaginal ultrasounds might be necessary for clearer images in very early stages, though this is not a direct criticism of the V6 itself.
  • One older review of a different Samsung portable ultrasound (MySono U5) mentioned that some presets might not be ideal, requiring user adjustment, which could potentially apply to newer models as well.

Based on reviews from: Samsung Medison V6 Ultrasound Machine: A Full Review and Clinical Test - YouTube, Samsung's V6 Ultrasound System, USA - Medical Device Network, Samsung Launches New Ultrasound System 'V6' Where Performance Meets Efficiency, Samsung V6 Ultrasound System Overview | PDF - Scribd, 2026 Ultrasound Machine Buyer's Guide: Prices & Top Brands | Probo Medical, Enhancing Women's Health Diagnostics with the Samsung V6, Comparison of 6 handheld ultrasound devices by point-of-care ultrasound experts: a cross-sectional study - PMC, V6 Women's Health Ultrasound - Samsung Healthcare USA, Samsung Launches New Ultrasound System 'V6' Where Performance Meets Efficiency, r/Ultrasound - Reddit, Question for those utilizing diagnostic ultrasound : r/physicaltherapy - Reddit, Samsung Medison MySono U5 Ultrasound Review - Probo Medical, Handheld ultrasound at 6w 6d showed.. nothing? : r/BabyBumps - Reddit, tell me your positive 6w2d ultrasound stories! : r/pregnant - Reddit, Need advice on a 6w3d ultrasound - Reddit, Samsung Medison V6 Ultrasound Introduction Review - YouTube, Comparison of 6 handheld ultrasound devices by point-of-care ultrasound experts: a cross-sectional study, Samsung Launches V6 Ultrasound System, Inspiring everyday efficiency - DuMed

Last updated: 2026-07-19

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Press & Coverage

GlobalData
Samsung Medison Receives 510(K) Clearance For V6 Diagnostic Ultrasound System
Samsung Medison received 510(k) clearance from the FDA for its V6 Diagnostic Ultrasound System on October 25, 2023. This clearance allows the company to market the device in the US.
2023-10
Scribd (FDA Document)
U.S. Food & Drug | PDF | Medical Ultrasound
The FDA determined that the V6 Diagnostic Ultrasound System, along with several other V-series systems, is substantially equivalent to existing devices, enabling its marketing under the 510(k) premarket notification process. These Class II devices are intended for various medical imaging applications and are for use by trained healthcare professionals.
2025-07
X-ray Interpreter (FDA Radiology AI Device)
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | FDA Radiology AI Device
The V6 Diagnostic Ultrasound System by Samsung Medison is a general-purpose diagnostic ultrasound system that acquires ultrasound data and displays it in multiple modes, including 2D, Doppler, and 3D/4D. It includes AI-based features like NerveTrack for nerve segmentation, enhancing diagnostic capabilities across various clinical applications.
2024-06
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
Samsung Medison's V6 Diagnostic Ultrasound System, among others in the V-series, received 510(k) clearance on July 18, 2025, as part of a comprehensive analysis of cardiology AI/ML clearances for that year. The clearance date for the V6 system is listed as April 1, 2025, with the FDA determination on July 18, 2025.
2026-01
accessdata.fda.gov
Samsung Medison Co., Ltd. Yujin Kim Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REP
An FDA document from February 2025 details the substantial equivalence determination for the V8/cV8, V7/cV7, V6/cV6 Ultrasound System, stating that no clinical studies were required to demonstrate its safety and effectiveness. The system includes a new transducer, BCL2-14, and complies with FDA-recognized standards.
2025-02
accessdata.fda.gov
510(k) Premarket Notification
A June 2026 FDA premarket notification lists the V6 Diagnostic Ultrasound System, along with other V-series systems, from Samsung Medison Co., Ltd. as having received clearance. The document identifies Yujin Kim as the applicant contact.
2026-06

Videos

Product demos, reviews, and walkthroughs for V6 Diagnostic Ultrasound System.

View all on YouTube

Frequently Asked Questions

The V6 system integrates several AI features, including ViewAssistu2122 for automatic recognition of imaging planes and anatomical labeling, and BiometryAssistu2122 for semi-automated fetal growth measurements, both designed to streamline documentation and improve workflow efficiency. Additionally, UterineAssistu2122 automatically measures uterine size and shape to aid in detecting abnormalities, and NerveTracku2122 provides real-time nerve detection for musculoskeletal applications, enhancing diagnostic confidence and reducing errors.
The V6 Diagnostic Ultrasound System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for commercial use, indicating it conforms to applicable medical device safety standards. While specific details on AI data privacy for the V6 are not extensively detailed, AI-powered medical devices generally require robust cybersecurity measures to protect sensitive patient data and comply with federal regulations.
A key limitation of AI in ultrasound is its operator dependency; the AI cannot compensate for areas not scanned, and image quality can vary significantly between operators. There are also concerns about potential biases if AI systems are trained on non-representative datasets, which could lead to inequitable treatment of certain patient groups. Therefore, AI should serve as a decision-support tool rather than replacing expert physician review.
The V6 focuses on women's health and urology with specific AI tools like UterineAssistu2122 and BiometryAssistu2122, while other major players like GE Healthcare, Philips Healthcare, and Siemens Healthineers also offer AI-enabled ultrasound systems with automated measurements and enhanced image quality across various specialties. Competitors often emphasize portable and point-of-care devices, and some offer AI for cardiac exams or cancer diagnoses.
The price for the Samsung V6 ultrasound system can range from approximately $23,385 to $47,170, with some listings showing higher prices in other regions. While the initial purchase covers the system, some advanced AI features or cloud storage solutions on ultrasound devices may require ongoing subscriptions or additional costs.
The V6 system's AI features are based on deep learning technology, suggesting they can be refined and updated over time with new data. Regular updates to AI systems are crucial to reflect changes in populations and disease patterns, helping to identify and correct any biases or inaccuracies.
While specific training programs for the V6 were not detailed, AI-driven tools in ultrasound can offer guidance and training directly through the device, assisting healthcare providers in acquiring and interpreting high-quality images. Effective integration of AI into workflows typically requires training and adaptation for medical professionals.

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