cV6 Diagnostic Ultrasound

by Samsung Medison Co.  · Based in South Korea → — Inspiring everyday efficiency with advanced AI ultrasound.
Cardiology Obstetrics & Gynecology Radiology
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Regulatory Status Disclosed

Overview

The Samsung cV6 Diagnostic Ultrasound System is a general-purpose, mobile, software-controlled diagnostic ultrasound system designed to enhance diagnostic capabilities and improve patient care. It is driven by Samsung’s core imaging platform, Crystal Architecture™, which provides exceptional 2D and color image quality, clarity, and penetration. The cV6 integrates advanced IT, image processing, semiconductor, and communication technologies for efficient and confident diagnosis across various medical fields.

The system features a range of AI-powered tools to optimize workflow and elevate clinical confidence. These include ViewAssist™ for automatic recognition of imaging planes and anatomy labeling, BiometryAssist™ for semi-automated fetal growth measurements, and UterineAssist™ for automatic measurement of uterine size and shape. Other AI-based features like HeartAssist™ aid in cardiac diagnosis by classifying images and providing measurement results, while EzAssist offers on-screen anatomical reference information. The cV6 also supports advanced diagnostic tools such as ElastoScan Mode for tissue stiffness assessment, Strain+ for quantitative wall motion analysis, and AutoIMT+ for cardiovascular risk screening.

Designed for versatility, the cV6 is adaptable to diverse medical environments, offering remote accessibility, streamlined workflows, a wide screen, and a compact design with battery capability for operational convenience. It is intended for use by, or under the supervision of, appropriately trained healthcare professionals in hospitals, private practices, clinics, and similar care settings.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Crystal Architectureu2122 imaging engine
  • ViewAssistu2122 (AI-powered imaging plane recognition and annotation)
  • BiometryAssistu2122 (AI-powered semi-automated fetal growth measurements)
  • UterineAssistu2122 (AI-powered automatic uterine measurement)
  • HeartAssistu2122 (Deep Learning-based cardiac image classification and measurement)
  • ElastoScan Mode (tissue stiffness assessment)
  • SonoSyncu2122 (real-time image sharing and remote consulting/training solution)
  • Mobile Export (secure image sharing to patient smartphones via QR code)
  • QuickPreset (one-click transducer and preset selection)
  • BatteryAssistu2122 (battery power for mobility and uninterrupted scanning)

Use Cases

  • General diagnostic imaging
  • Women's health (obstetrics, gynecology, reproductive endocrinology, infertility)
  • Cardiovascular assessment and diagnosis
  • Urological examinations
  • Musculoskeletal imaging
  • Vascular studies

What Physicians Need to Know

PACS Integration Method
Designed for seamless integration with PACS (Picture Archiving and Communication Systems) to facilitate image archiving, retrieval, and review. The system supports image transmission to PACS, streamlining the workflow within a hospital environment.
Reading Room Workflow Impact
Significantly enhances workflow efficiency and reduces keystrokes through AI-powered features. ViewAssistu2122 automatically recognizes imaging planes and labels anatomy, simplifying documentation and improving exam consistency. BiometryAssistu2122 offers semi-automated, one-click fetal growth measurements. UterineAssistu2122 automates the measurement of uterine size and shape. HeartAssistu2122 categorizes and provides measurement results for fetal heart diagnosis, reducing assessment time from 45-60 minutes to a few minutes.
AI Model Architecture (deep learning approach)
Utilizes deep learning algorithms for its AI features such as ViewAssistu2122, BiometryAssistu2122, UterineAssistu2122, and HeartAssistu2122. The system is powered by Samsung's Crystal Architectureu2122 imaging engine and leverages Intelu00ae Coreu2122 Ultra processors with integrated GPU and NPU accelerators for efficient on-device AI inferencing.
Processing Speed (per study)
While a general 'per study' speed isn't specified, AI applications like Live HeartAssist significantly reduce the time for fetal heart assessments from 45-60 minutes to 'only a few minutes'. Performance results for AI applications like Live HeartAssist show 200-250 FPS and NerveTrack 41-50 FPS, indicating real-time or near real-time processing for specific AI tasks.
FDA Clearance Pathway
Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for commercial use.
Supported Modalities
Diagnostic Ultrasound (US) for a wide range of clinical applications including Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac), and Peripheral vessel.
Sensitivity & Specificity Data
For the V6/cV6 system, a 'view recognition test' achieved a sensitivity of 93.97% and a specificity of 99.62%. A 'segmentation test' showed an average dice-score of 0.863.
RSNA/ACR Validation
Samsung Medison actively showcases its AI-based diagnostic solutions and ultrasound systems at major conferences like RSNA (Radiological Society of North America), demonstrating its commitment to advancing medical imaging technology. Specific ACR validation for the cV6 was not explicitly found.
Physician Tip

Leverage the cV6's AI-powered features like ViewAssistu2122, BiometryAssistu2122, UterineAssistu2122, and HeartAssistu2122 to significantly reduce manual steps, enhance diagnostic consistency, and improve overall efficiency in women's health and urology examinations. The real-time image sharing via SonoSyncu2122 can be invaluable for consultations and training. While the AI tools streamline measurements and annotations, always maintain clinical oversight and correlate AI outputs with comprehensive patient data for accurate diagnoses.

The cV6 is designed for seamless integration into existing radiology ecosystems through standard DICOM support for image and data transfer to PACS. Its compatibility with external AI platforms, such as Cycle Clarity's AI-based software platform for reproductive endocrinology and infertility, further extends its utility and integration potential.

Details

Category Radiology & Imaging AI
Pricing Contact for pricing — Not publicly available for medical devices; typically requires direct inquiry.
DeploymentOn-premise (mobile ultrasound system)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The cV6 Diagnostic Ultrasound System, along with other V-series models (V8/cV8, V7/cV7, V5/cV5, V4/cV4), received FDA 510(k) clearance (K250999) on July 18, 2025. It is classified as a Class II medical device (Product Code IYN, IYO, ITX, LLZ, QIH) for diagnostic ultrasound imaging and fluid flow analysis, found substantially equivalent to predicate devices.
Integrations
EHR Not specified
Specialties Cardiology, Obstetrics & Gynecology, Radiology

What the Web Says

The Samsung cV6 Diagnostic Ultrasound system is designed for cardiovascular care, offering exceptional image quality and advanced diagnostic performance. It incorporates AI-powered technologies and intuitive controls to streamline workflow and enhance diagnostic accuracy for cardiac and vascular conditions. The system is noted for its clarity, intelligent automation, and ergonomic design, making it suitable for various clinical environments.

Overall: Positive

Strengths

  • Exceptional imaging clarity and high-resolution visuals.
  • AI-enhanced diagnostic tools and intelligent automation for efficiency and consistent results.
  • Optimized cardiovascular workflow with user-focused controls and customizable settings.
  • Versatile clinical applications supporting a comprehensive range of cardiovascular and vascular assessments.
  • Modern, high-definition display and ergonomic design for superior usability and comfort.
  • Reliable performance and connectivity for data security and integration within healthcare networks.

Limitations

  • Specific user reviews from physicians, healthcare IT, tech reviewers, G2, Capterra, and Reddit for the Samsung cV6 were not readily available in the search results.
  • Some features, options, and transducers may not be commercially available in all countries.
  • Sales and shipments are effective only after regulatory approval, which could impact availability.

Based on reviews from: Scanmed Technology (S) Pte Ltd, Samsung Medison Co., LTD. (via image), Scribd (Samsung V6 Ultrasound System Overview)

Last updated: 2026-07-20

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Press & Coverage

Samsung Medison
Samsung Launches New Ultrasound System 'V6' Where Performance Meets Efficiency
Samsung Medison launched its new V6 ultrasound system in November 2023, featuring the Crystal Architectureu2122 imaging platform and AI-based features like ViewAssistu2122 to enhance image clarity, accuracy, and workflow efficiency in women's health and urology. The system is also compatible with Cycle Clarity's AI-based software platform for reproductive endocrinology and infertility settings.
2023-11
YouTube (MEDLIGA)
Samsung Medison V6 Ultrasound Machine: A Full Review and Clinical Test - YouTube
This video provides a detailed review and practical testing of the Samsung Medison V6 ultrasound machine, highlighting its interface, control panel, technologies like MVFlow and 5D options, and clinical application in various examinations. It also compares the V6 with the V7 model and assesses image quality and automatic functions.
2026-03
FDA
510(k) Premarket Notification - FDA
Samsung Medison Co., Ltd. submitted a 510(k) Premarket Notification for their V6 Diagnostic Ultrasound System, along with other V-series and cV-series systems, indicating regulatory clearance for these devices. The document lists Samsung Medison as the applicant and provides contact information.
2026-07
X-ray Interpreter (FDA Radiology AI Device)
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | FDA Radiology AI Device - X-ray Interpreter
This FDA approval entry details the V6 Diagnostic Ultrasound System by Samsung Medison, highlighting its general-purpose diagnostic capabilities, various imaging modes, and AI-based features like NerveTrack for nerve segmentation. The system received FDA approval on June 21, 2024.
2024-06
Medical Device Network
Samsung's V6 Ultrasound System, USA - Medical Device Network
The Samsung V6 ultrasound system, launched in November 2023, is powered by Crystal Architectureu2122 and offers advanced imaging capabilities and automated features for women's health and urology. It includes a miniER7 Endocavity Transducer designed for patient comfort and integrates with Cycle Clarity's AI-based software.
2024-03
FDA
Samsung Medison Co., Ltd. Yujin Kim Regulatory Affairs Specialist... - accessdata.fda.gov
This FDA document, dated July 18, 2025, confirms the 510(k) clearance for Samsung Medison's V6 Diagnostic Ultrasound System, along with other V-series and cV-series models. It details the intended use, device description, and updates to AI models for features like BiometryAssist, ViewAssist, and HeartAssist.
2025-07
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
This review of 2025 Cardiology AI/ML SaMD 510(k) clearances lists Samsung Medison's V6 Diagnostic Ultrasound System (and cV6) among other devices that received FDA clearance. The clearance date for these systems is noted as July 18, 2025.
2026-01
Scribd
Samsung cV Ultrasound Systems Overview | PDF | Heart | Diastole - Scribd
This overview document describes the Samsung cV8, cV7, and cV6 ultrasound systems, highlighting their intuitive control panels with easy-to-access CV modes and shockproof transducer designs for various applications like abdomen, MSK, and vascular imaging.
unknown

Videos

Product demos, reviews, and walkthroughs for cV6 Diagnostic Ultrasound.

View all on YouTube

Frequently Asked Questions

The Samsung cV6 Diagnostic Ultrasound system, powered by AI and automation, aims to enhance clinical confidence and efficiency. It includes features like HeartAssistu2122, which automatically classifies ultrasound images into necessary measurement views for heart diagnosis, and AutoIMT+ for automated intima-media thickness measurement. [15] These AI tools are designed to streamline diagnostic processes and support clinicians in managing higher scan volumes. [15, 19]
The Samsung cV6 Diagnostic Ultrasound system has received FDA 510(k) premarket notification clearance, indicating it is substantially equivalent to legally marketed predicate devices. [6, 7, 9] For AI-powered medical devices, compliance generally requires adherence to regulatory standards for safety, effectiveness, and data management, often including specific guidelines for AI/ML-based software as a medical device (SaMD). [18]
While specific comparative data for cV6's AI against all competitors isn't detailed, other major players like GE HealthCare and Philips also offer AI-powered ultrasound systems with features such as real-time guidance, automated measurements, and improved workflow. [10, 11, 13, 18, 19, 23] Different systems may excel in various specialties or ease of use, with some handheld devices also integrating strong AI features for point-of-care applications. [20, 21, 24]
Specific pricing for the cV6 Diagnostic Ultrasound system with its AI features is not publicly detailed in the search results. However, general diagnostic ultrasound costs can range from approximately $155 to $850 or more per exam, depending on the type and location. [8, 12, 33, 34] Portable cardiac ultrasound devices with AI features can range from $5,000 to $30,000, suggesting that advanced AI-integrated systems would be on the higher end, potentially involving initial purchase costs, maintenance contracts, and possible software licensing fees. [20]
AI in ultrasound faces limitations such as operator dependency, image variability, and the presence of noise sources, which can affect diagnostic accuracy. [1, 2, 3] AI models rely on large, diverse datasets for training, and if the dataset is limited or biased, the AI's performance may be inconsistent or lead to false positives, necessitating human oversight to avoid missed errors. [1, 4, 5]
While specific details for cV6 were not found, general diagnostic ultrasound systems must comply with privacy and information security best practices, often utilizing open standards like HL7 and FHIR for secure data exchange. [28] However, vulnerabilities have been identified in other ultrasound systems that could allow malicious actors to access or manipulate patient data, highlighting the importance of robust cybersecurity measures, including user permissions, password protection, and up-to-date operating systems like Windows 10 IoT with whitelisting features. [17, 22, 26, 27, 31]
Effective integration of diagnostic ultrasound systems, including those with AI like the cV6, with existing PACS and EMR systems is crucial for continuity of care and efficient workflow. Systems typically support integration using open standards such as HL7 and FHIR to automatically deliver reports and images in real-time. [25, 28] This ensures that high-quality scans and relevant patient information are accessible to authorized healthcare providers and maintain data integrity across different systems. [25]

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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