cV5 Diagnostic Ultrasound System
by Samsung Medison Co.
· Based in South Korea →
— Relentless Innovation for your diagnostic confidence.
Contact for pricing
Regulatory Status Disclosed
Overview
The Samsung cV5 Diagnostic Ultrasound System is a versatile and advanced imaging solution designed to deliver high-quality imaging across a broad spectrum of clinical needs. Built for clarity, efficiency, and ease of use, it supports confident decision-making in fast-paced healthcare environments. The system incorporates AI-assisted functions that streamline routine measurements and exam workflows, helping reduce scan time and improve consistency. With an intuitive interface, ergonomic controls, and a compact design, the cV5 enhances productivity for clinicians while ensuring a smooth and comfortable experience for patients. It integrates advanced imaging technologies like Crystal Architecture™ to deliver exceptional clarity and consistency, supporting a wide range of medical specialties with superior image quality.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Crystal Architectureu2122 with ClearVision, S-Harmonicu2122, HQ-Visionu2122, ShadowHDRu2122, MultiVision for enhanced image quality
- AI & Productivity Tools: HeartAssistu2122, AutoEF, Strain+, TMAD, AutoIMT+, ArterialAnalysisu2122, EzExam+u2122, EzCompareu2122, EzPrepu2122, SonoSyncu2122, QuickScanu2122, BiometryAssistu2122
- Broad compatibility with S-Vueu2122 transducers (1u201322 MHz) for diverse applications
- 21.5u201d or 23.8u201d Full HD LED monitor with IPS technology and 14u201d tilting touchscreen
- Multiple imaging modes: 2D, M-Mode, Color/Power Doppler, PW/CW Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), 3D/4D
- 512GB SSD + 1TB expanded storage for extensive data management
- Data export capabilities including AVI, MPEG, JPEG, TIFF, BMP, and DICOM formats
- Cybersecurity Suite with DICOM TLS and HL7 integration for secure data handling
- BatteryAssistu2122 for enhanced mobility and uninterrupted scanning
- SonoSyncu2122 for real-time image sharing and remote collaboration
Use Cases
- Fetal and Obstetrics imaging
- Abdominal imaging
- Gynecology examinations
- Adult and Pediatric Cardiac assessments
- Musculoskeletal (Conventional and Superficial) diagnostics
- Peripheral Vascular studies
What Physicians Need to Know
ECG/EKG Analysis Capability
The HeartAssistu2122 AI feature performs automated cardiac phase selection for measurements without requiring ECG, offering flexibility in various clinical scenarios.
Echocardiography AI Features
The cV5 system includes HeartAssistu2122 (Deep Learning-based automatic classification of ultrasound images into measurement views, automated measurements for LV, LA, RV, and multi-cycle measurements with up to 98% accuracy for view classification and 95-100% for measurements), Strain+ (quantitative tool for global and segmental wall motion of LV, LA, and RV), AutoEF (quantifies Ejection Fraction, LV volume, and Global Longitudinal Strain), AutoIMT+ (intima-media thickness measurement for cardiovascular disease risk), ArterialAnalysisu2122 (detects functional changes of vessels like stiffness and pulse wave velocity), StressEcho package (wall motion scoring and reporting), LumiFlowu2122 (3D-like appearance for color Doppler), MV-Flowu2122 (microvascular perfusion), and HQ-Visionu2122 (reduces image blurring).
Arrhythmia Detection Accuracy
While not providing a specific arrhythmia detection accuracy metric, the system's comprehensive cardiac function assessment tools, such as Strain+ and HeartAssistu2122 (which performs multi-cycle measurements to address inter-beat variability), can aid in identifying conditions associated with arrhythmias and support clinicians in managing complex heart conditions.
Heart Failure Risk Prediction
The cV5 offers AutoIMT+ and ArterialAnalysisu2122 as screening tools to assess a patient's potential risk of cardiovascular disease, including factors relevant to heart failure. AutoEF quantifies Ejection Fraction and Global Longitudinal Strain, which are key indicators for heart failure assessment.
Coronary Artery Assessment
ArterialAnalysisu2122 supports the early detection of cardiovascular disease by assessing functional changes in the common carotid artery (stiffness, intima-media thickness, pulse wave velocity). Advanced imaging features like MV-Flowu2122 and LumiFlowu2122 enhance the visualization of microvascular perfusion and blood flow, indirectly contributing to coronary health assessment.
AHA/ACC Guideline Alignment
The HeartAssistu2122 feature performs multi-cycle measurements, addressing inter-beat variability and aligning with clinical guidelines for accurate cardiac assessment.
Real-Time Alert Capability
The system's deep-learning algorithms provide real-time clinical insights and enable faster, more consistent diagnoses. HeartAssistu2122 delivers fast and accurate measurements in each echocardiogram view, supporting immediate diagnostic support.
Physician Tip
Leverage the cV5's AI-powered automation, such as HeartAssistu2122, to significantly streamline echocardiography workflows, reduce manual keystrokes, and minimize inter-observer variability, leading to more consistent and efficient cardiac assessments. Utilize AutoIMT+ and ArterialAnalysisu2122 for early cardiovascular disease risk stratification. The ability of HeartAssistu2122 to function without requiring ECG can be particularly beneficial in challenging clinical situations or for quick bedside assessments. Focus on the comprehensive suite of tools like Strain+ and AutoEF for detailed analysis of ventricular and atrial function, crucial for diagnosing and managing various cardiac conditions.
The HeartAssistu2122 AI solution is a built-in feature within Samsung Medison's cV ultrasound systems. While specific integrations with broader hospital IT systems (like EHR/PACS) are not explicitly detailed, modern ultrasound platforms typically support DICOM connectivity for seamless image and data transfer to facilitate integrated patient care workflows.
Details
| Category | Cardiology AI, OB/GYN AI, Radiology & Imaging AI |
| Pricing | Contact for pricing — Contact vendor for pricing information. |
| Deployment | On-premise hardware |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The cV5 Diagnostic Ultrasound System received FDA 510(k) clearance under K250999 on July 18, 2025. It is a general purpose, mobile, software-controlled diagnostic ultrasound system intended to acquire and display ultrasound data in various modes for diagnosing and monitoring medical conditions. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Obstetrics & Gynecology, Radiology |
What the Web Says
The Samsung cV5 Diagnostic Ultrasound System is a versatile, AI-assisted ultrasound platform designed for various medical specialties, including cardiology, OB/GYN, and radiology. It emphasizes high-quality imaging, streamlined workflows, and an ergonomic design to aid in confident decision-making. The system has received FDA clearance and is noted for its comprehensive suite of AI and productivity tools.
Overall: PositiveStrengths
- Versatile, all-in-one imaging solution for multiple specialties (Cardiology, OB/GYN, Radiology).
- Features AI tools like HeartAssistu2122, AutoEF, Strain+, and AutoIMT+ for enhanced diagnostic precision and consistency.
- Ergonomic design with a tilting touchscreen and smooth height adjustment, along with an intuitive user interface, contributes to superior usability.
- High-quality imaging with Crystal Architectureu2122 for enhanced clarity and noise reduction.
- Broad S-Vue transducer compatibility ensures versatility for diverse applications.
- HIPAA compliant with a Cybersecurity Suite including DICOM TLS and HL7 integration for secure data handling and interoperability.
Limitations
- Pricing information is not readily available; requires contacting the vendor.
- No specific ratings or detailed user reviews found on platforms like G2, Capterra, or Reddit.
- While versatile, specialized systems may offer deeper clinical value in their specific domains (e.g., dedicated cardiovascular ultrasound systems).
- Deployment as on-premise hardware might introduce more complex logistical and IT management challenges for large enterprises compared to software-only solutions.
Based on reviews from: Medical AI Tools for Physicians (Vertex AI Search), accessdata.fda.gov, Innolitics, Probo Medical, YouTube
Last updated: 2026-07-19
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Press & Coverage
accessdata.fda.gov
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
This FDA 510(k) premarket notification details the clearance of the cV5 Diagnostic Ultrasound System, alongside other V-series systems, outlining its intended use for obtaining ultrasound images and analyzing body fluids across various clinical applications.
2025-07
FDA Radiology AI Device - X-ray Interpreter
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
This article discusses the FDA approval of the V8 and V7 Diagnostic Ultrasound Systems, which are related to the cV5, highlighting their AI-based features like NerveTrack, BiometryAssist, ViewAssist, and HeartAssist for enhanced imaging and analysis.
2023-02
FDA Radiology AI Device
HERA W9, HERA W10 Diagnostic Ultrasound System
This entry details the FDA approval of the HERA W9 and HERA W10 Diagnostic Ultrasound Systems, which also incorporate AI-powered features like HeartAssist and BiometryAssist to improve efficiency and accuracy in various clinical applications.
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Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
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FDA.report
Automated Radiological Image Processing Software QIH
This regulatory entry lists the cV5 Diagnostic Ultrasound System under product code QIH, which pertains to automated radiological image processing software, indicating its inclusion of AI-based features.
2025-09
Videos
Product demos, reviews, and walkthroughs for cV5 Diagnostic Ultrasound System.
Samsung VET Ultrasound Portfolio
Samsung Healthcare USA
Frequently Asked Questions
The cV5 Diagnostic Ultrasound System integrates AI for various functions, including real-time image quality improvement, automated lesion detection and segmentation, and classification assistance. It can also provide real-time guidance during scans, potentially improving acquisition for less experienced users and streamlining diagnostic workflows.
For any medical AI device like the cV5, FDA clearance or approval is a critical regulatory step, indicating it meets safety and efficacy standards for its intended use. Regarding HIPAA, the system must adhere to strict privacy and security rules for Protected Health Information (PHI), which typically involves features like end-to-end encryption, access controls, audit logging, and a Business Associate Agreement (BAA) with the vendor.
While AI in diagnostic ultrasound can significantly improve efficiency and accuracy, its reliability depends heavily on the quality and diversity of its training data. Potential limitations include the risk of false positives or negatives, sensitivity to subtle image artifacts or noise, and difficulty generalizing to rare or atypical cases not well-represented in its training.
The cV5 system is designed with robust data protection measures, including secure data storage, end-to-end encryption for data in transit and at rest, and strict access controls. It also emphasizes de-identification of data whenever possible for AI model training and processing, along with comprehensive audit trails to monitor data access and usage, all in compliance with HIPAA regulations.
The cV5 is designed for seamless integration into existing clinical workflows, aiming to minimize disruption and enhance efficiency. It typically offers compatibility with various Electronic Health Record (EHR) systems and DICOM for image transfer and reporting. The learning curve for physicians is generally mitigated by intuitive interfaces and AI-guided features that assist with image acquisition and interpretation, though specific training is always recommended.
The pricing for AI-powered ultrasound systems like the cV5 often involves an initial hardware cost, which for portable devices can range from approximately $3,000 to $6,000. Additionally, many advanced AI features and cloud services are typically offered through an annual subscription model, which can range from a few hundred to over a thousand dollars per year.
Alternatives to the cV5 include traditional cart-based ultrasound machines, which offer comprehensive imaging but are less portable, and other handheld AI-powered devices such as Butterfly iQ+, Clarius, and Exo Iris. These alternatives vary in their specific AI capabilities, probe types, image quality, and pricing models, including subscription requirements for advanced features.
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| Last Verified: 2026-04-19 | First Added: 2026-04-19