V7 Diagnostic Ultrasound System

by Samsung Medison Co.  · Based in South Korea → — Performance Meets Versatility
Cardiology Obstetrics & Gynecology Radiology
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Regulatory Status Disclosed

Overview

The Samsung V7 Diagnostic Ultrasound System is a high-performance ultrasound scanner engineered to deliver superior imaging and diagnostic capabilities across diverse clinical applications. Powered by Samsung’s innovative Crystal Architecture™ (including CrystalBeam™ and CrystalLive™ technologies), the V7 provides exceptional image quality, resolution, and penetration for confident diagnoses, even in challenging cases.

The system is equipped with a suite of AI-powered tools and intelligent assist features designed to streamline workflow and enhance diagnostic precision. These include automated measurements and advanced imaging technologies that transform daily ultrasound practice. Its intuitive and ergonomic design, coupled with a compact footprint and touch-based control panel, makes it suitable for various medical settings, from busy hospitals to outpatient clinics.

The V7 is particularly well-suited for women’s health, general imaging, and cardiovascular assessments, offering specialized features for fetal monitoring, gynecological exams, liver, breast, thyroid, and musculoskeletal evaluations. Additionally, it supports point-of-care diagnostics with features like NeedleMate+™ for enhanced needle visualization during procedures.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Crystal Architectureu2122 (CrystalBeamu2122, CrystalLiveu2122) for enhanced 2D, 3D, and color imaging
  • AI-Powered Intelligent Assist features for diagnostic precision and workflow efficiency
  • BiometryAssistu2122 for automated fetal biometry measurements
  • 5D Heart Coloru2122 for semi-automated fetal heart evaluation
  • UterineAssistu2122 for automated uterine size and shape measurements using Deep Learning
  • S-Shearwave Imagingu2122 for quantitative, non-invasive assessment of tissue stiffness (e.g., breast, liver)
  • ShadowHDRu2122 for improved visualization in shadowed regions
  • MV-Flowu2122 for detailed visualization of microvascular perfusion
  • EzExam+u2122 and EzCompareu2122 for workflow optimization and consistent exams
  • SonoSyncu2122 for real-time ultrasound image sharing and remote control
  • NeedleMate+u2122 for enhanced needle visualization in point-of-care settings

Use Cases

  • Obstetrics and Gynecology (fetal monitoring, fertility assessments, uterine exams)
  • General Imaging (liver, breast, thyroid, musculoskeletal exams)
  • Cardiovascular Assessments (fetal heart evaluation, AutoIMT for cardiovascular risk)
  • Point-of-Care Diagnostics (bedside evaluations, needle-guided procedures)
  • Elastography (assessment of tissue stiffness in breast, liver, and cervical canal)
  • Interventional Procedures (lesion localization with S-Fusionu2122)

What Physicians Need to Know

ECG/EKG Analysis Capability
HeartAssistu2122 enables automated phase selection for cardiac measurements even without requiring ECG signals, offering flexibility. It supports multi-cycle measurements to account for inter-beat variability, aligning with clinical guidelines for accurate cardiac assessment.
Echocardiography AI Features
The V7 features HeartAssistu2122, an AI-powered solution for adult transthoracic echocardiography that automates view classification (up to 98% accuracy) and cardiac measurements (95-100% accuracy) across 20 echocardiographic views. This significantly reduces manual keystrokes (up to 93%) and measurement time (90%). It also automatically identifies 11 Doppler views and provides 25 measurements. Additionally, 5D Heart Coloru2122 is a semi-automated technology generating 9 simultaneous suggested echocardiography views to enhance screening for congenital heart disease. AutoEF assesses potential ejection fraction, and Strain+u2122 provides quantitative analysis of global and segmental left ventricular wall motion. A StressEcho package is also available for wall motion scoring and reporting.
Arrhythmia Detection Accuracy
While not a dedicated arrhythmia detection tool, HeartAssistu2122's ability to perform multi-cycle measurements and function without an ECG signal helps address inter-beat variability, which is particularly useful in patients with irregular rhythms like atrial fibrillation, ensuring more consistent measurements.
Heart Failure Risk Prediction
AutoIMT+u2122 serves as a screening tool to analyze a patient's potential risk for cardiovascular disease by providing easy, automated intima-media thickness measurements of the common carotid artery.
Coronary Artery Assessment
The system includes ArterialAnalysis for detecting functional blood vessel changes. AutoIMT+u2122 contributes to cardiovascular risk assessment by measuring carotid intima-media thickness. Advanced Doppler modes like MV-Flowu2122 and S-Flowu2122 visualize microvascular perfusion and blood flow in small and peripheral vessels with high detail and directional sensitivity.
AHA/ACC Guideline Alignment
HeartAssistu2122's multi-cycle measurement capabilities are designed to align with clinical guidelines for accurate cardiac assessment. The system also demonstrates adherence to established medical guidelines in other areas, such as S-Detectu2122 for Thyroid incorporating ATA, BTA, EU-TIRADS, and K-TIRADS guidelines, and S-Detectu2122 for Breast employing BI-RADS scores for standardized reporting.
Physician Tip

Leverage the V7's AI-powered HeartAssistu2122 for significant workflow efficiencies and enhanced diagnostic consistency in echocardiography, reducing manual steps and inter-observer variability. Utilize its capability to perform measurements even without a stable ECG signal for increased flexibility. Employ AutoIMT+u2122 for quick and reliable cardiovascular disease risk screening. The advanced flow visualization tools (MV-Flowu2122, S-Flowu2122) can provide deeper insights into vascular health, complementing comprehensive cardiac assessments.

The V7 system incorporates on-device AI solutions like HeartAssistu2122 for streamlined diagnostics. For enhanced collaboration and remote consultation, SonoSyncu2122 allows for real-time ultrasound image sharing, voice communication, and remote control, facilitating effective interaction between physicians and sonographers across different locations.

Details

Category Cardiology AI, OB/GYN AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentOn-premise (hardware)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

The Samsung V7 Diagnostic Ultrasound System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for commercial use. Its 510(k) premarket notification number is K250999.
Integrations
EHR Not specified
Specialties Cardiology, Obstetrics & Gynecology, Radiology

What the Web Says

The Samsung V7 Diagnostic Ultrasound System is a versatile and advanced imaging solution designed for a wide range of clinical applications, particularly excelling in women's health. It boasts exceptional image clarity and penetration, powered by Samsung's Crystal Architectureu2122, and integrates AI-powered features to enhance diagnostic precision and workflow efficiency. Physicians and healthcare providers highlight its ability to detect fetal anomalies earlier and improve outcomes in high-risk pregnancies.

Overall: Positive

Strengths

  • Exceptional image quality and clarity with high-resolution 2D, 3D, and color imaging.
  • Advanced AI-powered features for enhanced diagnostic precision and workflow efficiency (e.g., BiometryAssistu2122, UterineAssistu2122, HeartAssistu2122).
  • Versatile for a wide range of clinical applications, including women's health, cardiology, vascular, pediatric, abdominal, and musculoskeletal imaging.
  • User-friendly interface and streamlined workflow with customizable menus and one-touch scanning.
  • Early detection of fetal anomalies and improved outcomes in high-risk pregnancies.
  • Compact, lightweight, and portable with battery support for various medical settings.

Limitations

  • Limited independent user reviews available outside of promotional materials and product announcements.
  • Specific pricing information is not readily available in public reviews.
  • Potential learning curve for new users accustomed to other ultrasound systems, though generally described as intuitive.

Based on reviews from: AuntMinnie, Ultravision Medical Equipment, HHM Health, Samsung Healthcare (via YouTube, Lysis, Choice Medical Systems), HT Medical Devices, Imaging Technology News, BioSpace, Reddit (r/Sonographers)

Last updated: 2026-07-19

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Press & Coverage

RadAI Slice (FDA Radiology AI Device)
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | FDA Radiology AI Device
Samsung Medison's V8 and V7 Diagnostic Ultrasound Systems received FDA approval on February 13, 2023, for various clinical applications including fetal, abdominal, and cardiac imaging, incorporating AI-based tools like NerveTrack, BiometryAssist, ViewAssist, and HeartAssist for improved diagnosis and workflow efficiency.
2023-02
RadAI Slice (FDA Radiology AI Device)
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | FDA Radiology AI Device
Another FDA approval for the V8 and V7 Diagnostic Ultrasound Systems by Samsung Medison was granted on June 29, 2022, highlighting their use in a wide range of clinical applications and the integration of AI-supported nerve detection.
2022-06
Scribd (U.S. Food & Drug)
U.S. Food & Drug | PDF | Medical Ultrasound - Scribd
An FDA 510(k) Premarket Notification from July 18, 2025, indicates that the V7 Diagnostic Ultrasound System, along with other Samsung Medison systems, was determined substantially equivalent to existing devices, allowing its marketing as a Class II medical device.
2025-07
RadAI Slice (FDA Radiology AI Device)
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | FDA Radiology AI Device
On June 21, 2024, Samsung Medison's V7 Diagnostic Ultrasound System, among others, received FDA clearance as a general-purpose diagnostic ultrasound system with AI-based NerveTrack for nerve segmentation.
2024-06
accessdata.fda.gov
K223387.pdf - accessdata.fda.gov
An FDA document from February 13, 2023, details the intended use and technological features of the V8 / V7 diagnostic ultrasound system, emphasizing its broad clinical applications and substantial equivalence to predicate devices.
2023-02
accessdata.fda.gov
October 3, 2023 Samsung Medison Co., Ltd. Jee Young Ju Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gu - accessdata.fda.gov
An FDA 510(k) summary from October 3, 2023, outlines the V7 Diagnostic Ultrasound System's intended use across various clinical applications and its general-purpose, mobile, software-controlled design.
2023-10
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
A January 13, 2026, review of Cardiology AI/ML SaMD 510(k) Clearances for 2025 mentions Samsung Medison's V7 Diagnostic Ultrasound System among other cleared devices, highlighting its product codes and the date of FDA clearance.
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 - accessdata.fda.gov
An FDA document from February 12, 2025, details the intended use of the V7 Diagnostic Ultrasound System, emphasizing its use by trained healthcare professionals in various clinical settings for obtaining ultrasound images and analyzing body fluids.
2025-02

Videos

Product demos, reviews, and walkthroughs for V7 Diagnostic Ultrasound System.

View all on YouTube

Frequently Asked Questions

The V7's AI aims to streamline image acquisition by providing real-time guidance and optimizing parameters, potentially reducing scan times and improving consistency. For interpretation, it may offer automated measurements, lesion detection, or classification support, aiding in quicker and more objective diagnostic assessments.
The V7's AI software is designed to comply with relevant medical device regulations, such as FDA clearance or CE Mark, for its intended diagnostic uses. It incorporates robust data encryption, access controls, and anonymization features to ensure patient data privacy and adherence to HIPAA and other regional data protection standards.
The V7 differentiates itself through its specific AI algorithms, which may focus on particular specialties or or offer unique automation features compared to competitors. Physicians should evaluate its performance metrics, user interface, and clinical validation studies against other systems to determine the best fit for their practice needs.
The V7's pricing typically includes the base system, with AI features potentially bundled or offered as modular add-ons. There may be ongoing subscription costs for software updates, new AI algorithms, or cloud-based services, which should be clarified during the procurement process to understand the total cost of ownership.
While powerful, the V7's AI has limitations, such as potential reduced accuracy in rare pathologies, highly artifact-laden images, or patient populations underrepresented in its training data. Physicians must exercise clinical judgment and not solely rely on AI outputs, especially in ambiguous cases.
The V7's AI is designed for interoperability, typically supporting DICOM and HL7 standards for integration with PACS and EMR systems. IT requirements usually involve network bandwidth, secure data transfer protocols, and potentially dedicated server resources for optimal performance and data management.

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