V5 Diagnostic Ultrasound System
by Samsung Medison Co.
· Based in South Korea →
— From Basics to Brilliance: Step into a new era of healthcare with the Samsung V5 ultrasound system, combining outstanding imaging performance and advanced AI diagnostic features.
Contact for pricing
Regulatory Status Disclosed
Overview
The Samsung V5 Diagnostic Ultrasound System is a compact, mobile ultrasound device designed for a range of medical specialties. It integrates advanced imaging performance with AI-driven features to support diagnostic processes.
- What it does: The V5 system provides diagnostic ultrasound imaging with features aimed at enhancing image clarity and automating certain measurement and workflow tasks. It utilizes technologies such as Crystal Architecture™ for consistent image quality, HQ-Vision™ for detail sharpening, MV-Flow™ for microvascular flow visualization, and LumiFlow™ for 3D-like Doppler visualization.
- Who it is for: This system is intended for use across various medical specialties and care settings, including general imaging, obstetrics/gynecology, cardiovascular, musculoskeletal, internal medicine, and interventional radiology. Its compact design and optional battery support mobile use within clinics and practices, as well as for point-of-care applications.
- How it fits a clinical or practice workflow: The V5 is designed to streamline workflow through intuitive controls and automated features. Tools like EzExam+™ allow for predefined protocols to reduce repetitive steps, and BiometryAssist™ offers automated biometric measurements. SonoSync™ facilitates real-time image sharing for remote collaboration and training. BatteryAssist™ enables scanning without immediate AC power, supporting transport and immediate use.
- Notable capabilities: Key capabilities include S-Shearwave Imaging™ for non-invasive tissue stiffness assessment in areas like the breast and liver, and UterineAssist™ which uses deep learning to automatically measure uterine size and shape. For obstetrics, 5D Follicle™ measures ovarian follicles, and 5D CNS+™ provides fetal brain measurements. Other features include HeartAssist™ for automated cardiac measurements, S-Detect™ for thyroid lesion analysis, NerveTrack™ for real-time nerve localization, and NeedleMate+™ for improved needle visibility during interventions.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Advanced AI diagnostic features and automation technologies
- Outstanding 2D, 3D, and color image quality (Crystal Architectureu2122)
- Compact, slim, and powerful design for mobility and usability
- Workflow efficiency with intuitive controls and automated features (EzExam+u2122, EzTrainer+u2122)
- HQ-Visionu2122 for sharper detail and reduced blurring
- MV-Flowu2122 and LumiFlowu2122 for detailed microvascular flow visualization
- Intelligent assist tools: HeartAssistu2122 (automated cardiac measurements), S-Detectu2122 for Thyroid (lesion analysis), NerveTracku2122 (real-time nerve localization)
- ElastoScanu2122 / S-Shearwave Imagingu2122 for tissue stiffness assessment
- NeedleMate+u2122 for improved needle visibility during interventions
- SonoSyncu2122 for real-time image sharing on PC and smartphone, BatteryAssistu2122 for portable use
Use Cases
- General imaging diagnostics
- Women's health (Obstetrics and Gynecology)
- Cardiovascular examinations
- Musculoskeletal diagnostics and interventions
- Point-of-care ultrasound
- Interventional radiology procedures
- Veterinary diagnostics
What Physicians Need to Know
DICOM Support & Standards
The V5 Diagnostic Ultrasound System supports DICOM protocol for sharing worklist and receiving image data, featuring a built-in DICOM server. It offers DICOM services for Storage and Worklist, capable of sending images on end exam in uncompressed single or multi-frame formats.
PACS Integration Method
The system integrates with PACS servers via the DICOM protocol, allowing for archiving images and data in centralized or distributed servers. This integration facilitates the consolidation and organization of images and data from various sources and modalities.
Reading Room Workflow Impact
Intelligent AI functionalities and intuitive controls streamline diagnostics, enabling quicker and more accurate assessments. Features like EzExam+u2122 reduce repetitive tasks, while SonoSyncu2122 supports real-time remote collaboration and image sharing. BatteryAssistu2122 enhances mobility for portable use, and the system offers remote accessibility and a larger screen view for improved efficiency.
AI Model Architecture (deep learning approach)
The V5 incorporates advanced AI diagnostic features, leveraging deep learning for several intelligent assist tools. These include BiometryAssistu2122 for automatic fetal biometric measurement, HeartAssistu2122 for automated cardiac measurements, S-Detectu2122 for Breast for lesion analysis and BI-RADS ATLAS classification, NerveTracku2122 for real-time nerve localization, 5D CNS+u2122 for fetal brain measurements, and UterineAssistu2122 for uterine size and shape measurement. The system utilizes Intelu00ae Coreu2122 Ultra processors with CPU cores, GPU, and NPU to accelerate AI inferencing.
Processing Speed (per study)
While a general 'per study' speed is not specified, the complete Samsung S-Shearwave Imaging pipeline, optimized with Intel, can run in under 150 milliseconds. Specific optimizations reduced cross-correlation compute times from 112 milliseconds to 24 milliseconds.
FDA Clearance Pathway
The V5 Diagnostic Ultrasound System received 510(k) clearance from the FDA, determined to be 'Substantially Equivalent' to predicate devices. The decision date for the K242511 submission, which includes the V5, was December 10, 2024.
Supported Modalities
The V5 is a Diagnostic Ultrasound System, supporting various ultrasound imaging modes including 2D, M-mode, PW Doppler, CW Doppler, Color Doppler, TDI, TDW, Power Amplitude Doppler, S-Harmonic, S-Flow, Color M-Mode, 3D/4D Imaging, and Elastoscan+. It is designed for a broad range of clinical applications such as Fetal/Obstetrics, Abdominal, Gynecology, Cardiac, and Musculoskeletal.
Sensitivity & Specificity Data
Specific sensitivity and specificity data for the V5 system or its AI features were not explicitly provided in the available information. The FDA 510(k) summary indicated that clinical studies were not required to demonstrate substantial equivalence.
RSNA/ACR Validation
The S-Detectu2122 for Breast feature on the V5 system applies BI-RADS ATLAS, which is a registered trademark of ACR, indicating adherence to ACR standards for breast imaging reporting. Samsung Medison has a history of showcasing FDA-cleared systems at RSNA and focuses on delivering validated AI solutions.
Physician Tip
Leverage the V5's integrated AI tools like BiometryAssistu2122 and HeartAssistu2122 for automated measurements to enhance consistency and reduce scan time, particularly in high-volume settings. Utilize SonoSyncu2122 for real-time remote consultations and training, fostering collaboration and improving diagnostic confidence. The system's mobility, supported by BatteryAssistu2122, makes it ideal for diverse clinical environments, including point-of-care and interventional procedures. Integrate the V5 seamlessly with your PACS for efficient image archiving and access, streamlining your overall workflow.
The V5 Diagnostic Ultrasound System offers robust DICOM 3.0 compliance, ensuring seamless integration with existing PACS and RIS for worklist management, image storage, and data exchange. Its built-in DICOM server facilitates direct communication. The system's AI features, powered by Intelu00ae Coreu2122 Ultra processors, are designed to integrate into the diagnostic workflow, providing intelligent assistance without requiring separate AI platforms for basic analysis. Compatibility with industry standards like BI-RADS ATLAS further enhances its interoperability within established clinical reporting frameworks.
Details
| Category | Radiology & Imaging AI |
| Pricing | Contact for pricing — Minimum price: $25,803; Maximum price: $38,928 (based on marketplace listings for new/demo units). |
| Deployment | On-platform (stationary with mobility features) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The V5 Diagnostic Ultrasound System (K250999) received FDA 510(k) clearance, indicating it is substantially equivalent to legally marketed predicate devices. It is designed to obtain ultrasound images and analyze body fluids for various clinical applications, including Fetal/Obstetrics, Abdominal, Gynecology, Cardiac, Musculoskeletal, and more. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Obstetrics & Gynecology, Radiology |
What the Web Says
The Samsung V5 Diagnostic Ultrasound System is a compact and mobile system designed for a wide range of medical specialties, including general imaging, women's health, cardiovascular, and musculoskeletal examinations. It features advanced imaging technologies like Crystal Architectureu2122, HQ-Visionu2122, MV-Flowu2122, and LumiFlowu2122 for exceptional clarity and detail. The system also incorporates AI-powered intelligent assist tools to streamline diagnostics and enhance workflow efficiency.
Overall: PositiveStrengths
- Exceptional image quality and clarity with advanced imaging technologies (Crystal Architectureu2122, HQ-Visionu2122, MV-Flowu2122, LumiFlowu2122).
- Compact, portable, and ergonomic design for mobility and usability in various clinical settings.
- AI-powered intelligent assist tools (HeartAssistu2122, S-Detectu2122, NerveTracku2122, ElastoScanu2122, NeedleMate+) for automated measurements and enhanced diagnostic precision.
- Streamlined workflow with intuitive controls, automated features (EzExam+u2122, EzTrainer+u2122), and remote collaboration (SonoSyncu2122).
- Supports a broad range of medical specialties, including general imaging, women's health, cardiovascular, and musculoskeletal.
- BatteryAssistu2122 enables portable use and quick scanning without AC power.
Limitations
- Limited independent reviews from physicians and tech reviewers outside of promotional materials.
- No specific negative feedback found on G2, Capterra, or Reddit in the search results.
- One Reddit user noted that image storage solutions and EMR integration often disappoint in practice, despite manufacturer claims, which could be a potential concern for any system, including the V5.
- Some advanced features may be optional and require additional purchase.
Based on reviews from: Samsung Medison (Product Page), Mid-South Medical Imaging, Scribd, SMD Medical AG, IndiaMART, Bio Imaging, accessdata.fda.gov, Reddit, YouTube
Last updated: 2026-07-21
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Press & Coverage
accessdata.fda.gov
V5/cV5, V4/cV4 Diagnostic Ultrasound Systems - FDA 510(k) Premarket Notification
This FDA premarket notification details the V5/cV5 and V4/cV4 Diagnostic Ultrasound Systems, describing them as general-purpose, mobile, software-controlled systems for acquiring and displaying ultrasound data in various modes for a wide range of clinical applications. The document outlines the device's intended use, modes of operation, and compliance with safety standards.
2025-07
FDA
510(k) Premarket Notification - K242511
This FDA 510(k) premarket notification for the V5, H5, XV5, XH5, V4, H4, XV4, XH4 Diagnostic Ultrasound Systems from Samsung Medison Co., Ltd. outlines their intended use for obtaining ultrasound images and analyzing body fluids across various clinical applications. It also mentions the inclusion of AI-based features like BiometryAssist, HeartAssist, ViewAssist, UterineAssist, and NerveTrack.
2025-12
RadAI Slice
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | FDA Radiology AI Device
This article discusses the FDA approval of Samsung Medison's V8 and V7 Diagnostic Ultrasound Systems, highlighting their advanced features including AI-based tools like NerveTrack, BiometryAssist, ViewAssist, and HeartAssist for improved diagnosis and workflow efficiency. It also mentions the V5 Diagnostic Ultrasound System in the context of other Samsung Medison devices.
2023-02
RadAI Slice
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | FDA Radiology AI Device
This piece covers the FDA approval of Samsung Medison's HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound Systems, noting their versatile imaging capabilities and AI-based features for image recognition and measurement. The V5 Diagnostic Ultrasound System is listed among other related devices.
2024-10
RadAI Slice
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | FDA Radiology AI Device
This article details the FDA clearance of Samsung Medison's V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound Systems, emphasizing their multi-mode imaging and AI-based NerveTrack feature. The V5 Diagnostic Ultrasound System is referenced as part of Samsung Medison's broader ultrasound portfolio.
2024-06
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
This review of 2025 cardiology AI/ML SaMD 510(k) clearances includes Samsung Medison's V8, cV8, V7, cV7, V6, cV6, V5, cV5, V4, and cV4 Diagnostic Ultrasound Systems, highlighting their regulatory approval and product codes.
2026-01
RadAI Slice
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System | FDA Radiology AI Device
This article discusses the FDA approval of the HERA W9 and HERA W10 Diagnostic Ultrasound Systems, noting their mobile, software-controlled design and various imaging modes. The V5 Diagnostic Ultrasound System is mentioned in the context of other Samsung Medison ultrasound devices.
2022-04
FDA.report
Samsung Medison Co., Ltd. March 27, 2026 Yoojung Choi Regulatory Affairs Specialist 3366, Hanseo-Ro, Nam-Myeon Hongcheon-Gun, G - FDA.report
This regulatory document from the FDA lists the EVO Q30, EVO Q20, EVO Q10, EVO XQ30, EVO XQ20, EVO XQ10, EVO QH30, EVO QH20, EVO QH10 Diagnostic Ultrasound Systems, along with the V5, cV5, V4, and cV4 Diagnostic Ultrasound Systems, detailing their general purpose, portable/mobile, software-controlled nature and broad clinical applications.
2026-03
Videos
Product demos, reviews, and walkthroughs for V5 Diagnostic Ultrasound System.
THE BEST Ultrasound Model Available #samsung #ultrasoundscan #regenerativemedicine
Frequently Asked Questions
The V5 system's AI is designed to enhance diagnostic accuracy by improving image quality, reducing noise, and automatically identifying patterns and anomalies that might be missed by less experienced operators. It streamlines workflow by automating tasks like measurements and data analysis, allowing physicians to focus more on patient care and complex cases.
The V5 system's AI algorithms would typically require regulatory approvals such as FDA 510(k) clearance or a CE Mark for their specific diagnostic assistance functions. To ensure patient data privacy, the system adheres to regulations like HIPAA and GDPR through robust encryption, anonymization protocols, and secure data handling practices, although the rapid advancement of AI can challenge existing regulations.
The V5 system likely differentiates itself through proprietary deep learning models tailored for specific anatomies or its intuitive user interface for AI integration, aiming for real-time adaptive scanning or comprehensive reporting automation. While many AI ultrasound systems offer similar benefits like improved diagnostic accuracy and efficiency, the V5 would highlight its unique selling propositions in areas such as specific diagnostic applications or ease of use.
The pricing for AI-powered ultrasound systems often includes the base hardware, with AI features potentially bundled or offered as a subscription for continuous updates and new algorithm releases. While initial costs for AI-based devices and software can be a deterrent, long-term cost savings may be realized through reduced need for repeat scans and expanded service offerings.
The V5 system's AI, like all AI in medical imaging, has limitations such as potential performance variations with atypical patient anatomies, operator dependency, or image quality issues. These limitations, along with the datasets used for training and potential for false positives, are typically communicated transparently in user manuals and during training to ensure informed clinical decision-making.
Yes, the V5 system is designed to integrate with most standard PACS and EMR systems, typically utilizing DICOM and HL7 protocols for automated image transfer and reporting. This integration aims to streamline workflows, reduce manual effort, and provide a comprehensive view of patient data within a single interface, enhancing diagnostic efficiency.
The V5 system's AI algorithms would be supported by rigorous clinical validation studies, often peer-reviewed, demonstrating their accuracy and efficacy in specific diagnostic applications. These studies are crucial for establishing trust and credibility, evaluating performance in real-world settings, and are often required for regulatory approval.
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| Last Verified: 2026-04-19 | First Added: 2026-04-19