HERA W10 Diagnostic Ultrasound System

by Samsung Medison Co.  · Based in South Korea → — Relentless Innovation for your diagnostic confidence.
Maternal-Fetal Medicine Obstetrics & Gynecology Radiology
Website
Claim this tool
Is this the maker? Claim the company →

Varies significantly based on configuration, probes, and new vs. refurbished status.
Regulatory Status Disclosed

Overview

The Samsung HERA W10 Diagnostic Ultrasound System is a premium platform designed to elevate diagnostic confidence and streamline workflow, particularly in women’s health. Powered by Crystal Architecture™, which integrates CrystalBeam™ beamforming and CrystalLive™ image processing with S-Vue Transducer™ technology, it delivers exceptional image clarity, uniformity, and advanced 3D/4D rendering.

The system incorporates advanced AI-powered features such as ViewAssist™, HeartAssist™, and BiometryAssist™ to automate measurements, classify images, and annotate structures, reducing repetitive tasks and enhancing consistency. It offers sophisticated tools like Advanced MV-Flow™ and LumiFlow™ for detailed visualization of microvascular perfusion and three-dimensional vascular images.

Designed with user comfort in mind, the HERA W10 features an adaptable ergonomic design, including a wide-range movable control panel and a large 27-inch OLED monitor, aiming to reduce operator strain during long scanning sessions. It is committed to supporting life-long healthcare for women, offering intuitive visualizations, precise analytic features, and fast operation for a more meaningful ultrasound experience.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Crystal Architectureu2122 (CrystalBeamu2122 & CrystalLiveu2122) for superior image clarity
  • AI-powered ViewAssistu2122 for automated measurements and annotations
  • AI-powered HeartAssistu2122 for automated fetal heart diagnosis views
  • AI-powered BiometryAssistu2122 for streamlined fetal growth measurements
  • Advanced MV-Flowu2122 and LumiFlowu2122 for detailed blood flow visualization
  • 27-inch OLED monitor for realistic image representation
  • Ergonomic design with wide-range movable control panel and monitor
  • ShadowHDRu2122 for shadow suppressed imaging in attenuated regions
  • HQ-Visionu2122 for high-resolution images and clinical detail
  • 5D CNS+u2122 and 5D NT for simplified fetal brain and nuchal translucency assessment

Use Cases

  • High-risk pregnancy examination and early diagnosis of abnormal fetal conditions
  • Comprehensive obstetrics and gynecology diagnostics
  • Automated fetal growth analysis and reporting
  • Detailed visualization of microvascular perfusion in tissues and organs
  • Elective 3D/4D ultrasound imaging for keepsake studios
  • General imaging, cardiovascular, and pediatric applications

What Physicians Need to Know

Fetal Monitoring AI
The HERA W10 system incorporates AI tools such as HeartAssistu2122 for automated fetal heart measurements, providing 44 automatic measurements, 31 annotations, and Z-Score calculations for comprehensive fetal heart assessment. BiometryAssistu2122 utilizes deep learning to enable one-click fetal growth measurements, including BPD, HC, AC, and FL, enhancing consistency and workflow efficiency. Additionally, 5D CNS+u2122 simplifies fetal brain assessment by automatically providing six measurements from three transverse views, improving reproducibility. 5D Limb Vol.u2122 is a semi-automated tool for quickly and accurately measuring upper arm or thigh volumes to estimate fetal weight and assess nutritional status. The 5D Heartu2122 feature offers AI-guided cardiac views to simplify fetal heart assessment.
Ultrasound Image Analysis
The HERA W10 features ViewAssistu2122, an AI technology that automatically recognizes imaging planes, labels anatomy, and provides fetal biometric measurements to streamline documentation and improve exam workflow. Its Crystal Architectureu2122 (combining CrystalBeamu2122 and CrystalLiveu2122 with S-Vue Transduceru2122 technology) delivers exceptional image clarity, enhanced 2D processing, advanced 3D rendering, and superior color signal processing. Advanced visualization tools like MV-Flowu2122 and LumiFlowu2122 offer detailed 2D and 3D views of blood flow and microvascular structures, aiding in the detection of tiny vascular structures and assessment of fetal circulation. ShadowHDRu2122 provides shadow-suppressed images for highly attenuated regions like the fetal head and spine, while HQ-Visionu2122 ensures high-resolution images for detecting critical details.
Pregnancy Risk Assessment
The HERA W10 is designed to facilitate the examination of high-risk pregnancies and the early diagnosis of abnormal fetal conditions. It integrates advanced AI tools for superior women's health diagnostics, including automated fetal growth analysis and comprehensive reporting, which can enhance clinical confidence in assessing potential risks.
Maternal Health Monitoring
While primarily focused on fetal imaging, the system's advanced MV-Flowu2122 and LumiFlowu2122 technologies can also be utilized to assess maternal circulation. The HERA W10 Elite also includes UterineAssistu2122, an AI-based solution that automatically measures uterine size.
Physician Tip

Leverage the AI-powered automation features like HeartAssistu2122, BiometryAssistu2122, and ViewAssistu2122 to significantly reduce manual measurement time and improve consistency in fetal assessments. Utilize the advanced imaging capabilities, including Crystal Architectureu2122, MV-Flowu2122, and LumiFlowu2122, for enhanced visualization of complex anatomies and microvascular structures, which can lead to earlier and more confident diagnoses in both obstetrics and gynecology. The ergonomic design and customizable interface contribute to a more comfortable and efficient scanning experience, especially during lengthy examinations. Integrate SonoSyncu2122 for real-time remote consultations and training, fostering collaboration and knowledge sharing.

The HERA W10 system features SonoSyncu2122, enabling real-time ultrasound scanning images to be viewed remotely on various devices such as smartphones, laptops, and desktop PCs. This facilitates two-way communication through voice chatting and marking, supporting multi-location real-time training, education, and remote consultations among healthcare professionals. The system's comprehensive reporting capabilities and automated measurements are designed to streamline workflow, suggesting potential for integration with electronic medical record (EMR) systems for efficient data management and documentation.

Details

Category OB/GYN AI, Radiology & Imaging AI
Pricing Varies significantly based on configuration, probes, and new vs. refurbished status.
  • Mid $30K to $60K USD (new/refurbished); Brand-new Elite units list north of $150K USD; Refurbished 2019–2021 systems average $32K–$42K USD
DeploymentOn-premise (hardware system)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The HERA W10 Diagnostic Ultrasound System has received FDA 510(k) clearance (K242444) as of November 27, 2024, for diagnostic ultrasound imaging and fluid flow analysis across various clinical applications.
Integrations
EHR Not specified
Specialties Maternal-Fetal Medicine, Obstetrics & Gynecology, Radiology

What the Web Says

The HERA W10 Diagnostic Ultrasound System by Samsung Medison is a general-purpose, mobile, software-controlled ultrasound system intended for diagnostic imaging and fluid analysis across various clinical applications, including obstetrics, gynecology, cardiology, and more. It is designed for use by trained healthcare professionals in hospitals, private practices, and clinics. The system has received FDA clearance, with recent clearances in 2023 and 2024, indicating its compliance with regulatory standards.

Overall: Positive

Strengths

  • General purpose and mobile, suitable for various clinical environments.
  • Software-controlled with multiple imaging modes (2D, M-mode, Doppler, 3D/4D).
  • Features advanced tools like 4D, CW function, DICOM, MV-Flow, and LumiFlo.
  • FDA-cleared, ensuring regulatory compliance and safety.
  • Supports remote diagnostic reviews and viewing.
  • Includes a 14-inch touch monitor as an option.

Limitations

  • Limited independent physician or tech reviews publicly available.
  • No specific negative feedback found in the search results.
  • No information from G2, Capterra, or Reddit was found, which might offer more user-generated pros and cons.

Based on reviews from: Physician Ai Tools, Samsung Medison Co., Bimedis, Radiology AI Tools Directory, FDA.report, accessdata.fda.gov

Last updated: 2026-07-19

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate HERA W10 Diagnostic Ultrasound System

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Health Canada
Regulatory Decision Summary - HERA W10 DIAGNOSTIC ULTRASOUND SYSTEM
Health Canada issued a Class III license for the HERA W10 Diagnostic Ultrasound System, a general-purpose, mobile, software-controlled system for various clinical applications. Safety and effectiveness were supported by compliance with standards, biocompatibility, acoustic output, and software validation.
2019-01
Canada.ca
Update on New Drug and Medical Device Authorizations - Canada.ca
Health Canada announced the approval of the Hera W10 Diagnostic Ultrasound System in June 2019, among other new drugs and medical devices, for general ultrasound examinations. This was part of an update on authorizations to provide Canadians with timely access to treatments.
2019-07
RadAI Slice
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System | FDA Radiology AI Device - X-ray Interpreter
The FDA approved the HERA W9/HERA W10 Diagnostic Ultrasound Systems on April 5, 2022. These systems are general-purpose, mobile, software-controlled diagnostic ultrasound systems that acquire and display ultrasound data in various modes for a wide range of clinical applications.
2022-04
FDA
510(k) Premarket Notification - FDA
Samsung Medison Co., Ltd. received a 510(k) premarket notification clearance from the FDA for the HERA W10 Diagnostic Ultrasound System, along with the HERA W9 system, on April 21, 2023.
2023-04
PMC (PubMed Central)
Assessment of fetal lung maturity and prediction of neonatal respiratory distress syndrome by MV-Flow imaging - PMC
A single-center prospective study conducted from May 2023 to August 2024 utilized the HERA W10 Diagnostic Ultrasound System to assess fetal lung maturity and predict neonatal respiratory distress syndrome using MV-Flow imaging. The study highlights the system's role in advanced obstetric ultrasonography.
2024-05
FDA
K242444 u00b7 HERA W10 Diagnostic Ultrasound System; HERA W9 ...
The FDA cleared the HERA W10 Diagnostic Ultrasound System, along with the HERA W9 system, on November 27, 2024, classifying it as a Class II medical device.
2024-11
FDA
November 27, 2024 Samsung Medison Co., Ltd. So-Yeon Jang Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, - accessdata.fda.gov
A 510(k) summary prepared in August 2024 details the HERA W9/HERA W10 as a general-purpose, mobile, software-controlled diagnostic ultrasound system with various imaging modes and clinical applications. The submission concluded substantial equivalence to predicate devices, with no clinical studies required.
2024-11

Videos

Product demos, reviews, and walkthroughs for HERA W10 Diagnostic Ultrasound System.

View all on YouTube

Frequently Asked Questions

The HERA W10 integrates AI features such as HeartAssistu2122, ViewAssistu2122, and BiometryAssistu2122 to automate measurements, classify images, and annotate structures in fetal assessments. These tools streamline workflows, reduce repetitive tasks, and enhance diagnostic confidence by providing consistent measurements for fetal growth parameters.
The AI features within the HERA W10, including HeartAssist, ViewAssist, and the AI version of BiometryAssist, have received FDA 510(k) clearance. This indicates that the system and its AI components have been deemed substantially equivalent to a legally marketed predicate device, affirming their safety and effectiveness for diagnostic use.
Key alternatives to the HERA W10 include the GE Voluson E10, GE Voluson E8, and Philips EPIQ 7, all offering advanced 3D/4D imaging and AI-driven features for women's health. While the HERA W10 is noted for its intuitive workflow and 'Instagrammable' images, competitors like the Voluson E10 are recognized for strong clinical credibility and imaging depth, with varying AI focuses such as automated Doppler or advanced biometry.
The price for a Samsung HERA W10 in 2025 can range from mid $30,000 to $60,000 USD, depending on whether it's new or refurbished, the number and type of probes included, and optional software packages. Factors such as advanced HDLive imaging, extended warranties, and installation/training also significantly impact the final cost.
While the HERA W10's AI tools enhance efficiency and consistency, they are assistive technologies and not a replacement for comprehensive clinical judgment. In complex or atypical cases, physicians must still apply their diagnostic expertise, as AI algorithms may have inherent limitations in interpreting highly variable or rare anatomical presentations.
As a medical device, the HERA W10 is designed to comply with stringent data privacy and security regulations, such as HIPAA. While specific details on its internal data handling for AI processing are not publicly detailed, it is expected to involve secure local processing or anonymized data transfer if cloud-based AI is utilized, adhering to established healthcare data protection standards.

Related Tools

AI-Powered OBGYN & Gynecologic Chats
Doctronic
Clinical Decision Support & Reference
Doctronic's AI-Powered OBGYN & Gynecologic Chats provide fast, personalized guidance for menstrual health, pregnancy support, UTIs, and reproductive care using advanced AI.
Free chat, $39/video visit with a doctor, prescription renewals starting at $0.
Mirvie
Mirvie
Clinical Decision Support & Reference
Mirvie is shaping the future of pregnancy health by providing women, expecting parents, and their doctors with an early detection window to intervene before unexpected pregnancy complications become a crisis.
Babyscripts
Babyscripts
OB/GYN AI
Babyscripts helps care teams close the loop on maternal risk with configurable screening and monitoring tools that connect patients to the right care pathway for timely, coordinated follow-up.
Subscription-based model
Butterfly Gestational Age Tool
Butterfly Network
OB/GYN AI
The Butterfly Gestational Age Tool is an AI-powered ultrasound feature designed to assist in rapid and accurate gestational age estimation.
Starts at $2,699 for the handheld probe, plus a required membership subscription.
AI-powered Postpartum Depression Risk Prediction Model (integrated into Epic)
NewYork-Presbyterian and Weill Cornell Medicine
Clinical Decision Support & Reference
An AI-powered risk prediction model developed at NewYork-Presbyterian and Weill Cornell Medicine uses data in electronic health records to identify pregnant patients at risk for postpartum depression (PPD), enabling preventive care. Integrated directly into Epic, the tool flags medium- to high-risk patients within physicians' workflows and provides risk scores, contributing factors, and suggested interventions to support clinical decision-making.
Natural Cycles (NC° Fertility Algorithm)
Natural Cycles
OB/GYN AI
Natural Cycles is an FDA-cleared birth control app with an AI-powered fertility algorithm that combines statistical modeling with machine learning to generate individualized fertility predictions. It's designed to help women prevent or plan pregnancies and offers support for various stages of their reproductive journey, from birth control to perimenopause. [4, 7, 18]
Subscription-based

See all OB/GYN AI tools →

More from Samsung Medison Co.

cV4 Diagnostic Ultrasound System
Samsung Medison Co.
Cardiology AI
The Samsung Medison cV4 is an AI-enabled, fanless diagnostic ultrasound system offering advanced imaging, streamlined workflows, and robust data security for diverse clinical applications.
Contact for pricing
cV5 Diagnostic Ultrasound System
Samsung Medison Co.
Cardiology AI
The Samsung cV5 Diagnostic Ultrasound System is a versatile, AI-assisted ultrasound solution offering high-quality imaging, streamlined workflows, and ergonomic design for confident decision-making across various medical specialties.
Contact for pricing
cV6 Diagnostic Ultrasound
Samsung Medison Co.
Radiology & Imaging AI
The Samsung cV6 Diagnostic Ultrasound System is a mobile, software-controlled diagnostic ultrasound system featuring advanced imaging capabilities and AI-powered tools for enhanced clarity and efficient diagnostics across various medical specialties.
Contact for pricing
cV7 Diagnostic Ultrasound System
Samsung Medison Co.
Radiology & Imaging AI
The Samsung cV7 Diagnostic Ultrasound System offers advanced AI-powered imaging with Crystal Architecture™ for exceptional clarity and a suite of Intelligent Assist features to enhance diagnostic confidence and workflow efficiency across various medical specialties.
Contact for pricing

View company profile →

Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
AI Tool Finder
AI-powered search. Results may not be comprehensive.