HM70 EVO Diagnostic Ultrasound System

by Samsung Medison CO.  · Based in South Korea → — High-performance portable ultrasound for confident diagnosis.
Emergency Medicine Obstetrics & Gynecology Radiology

Paid, one-time purchase
Regulatory Status Disclosed

Overview

The Samsung HM70 EVO Diagnostic Ultrasound System is a high-performance, hand-carried ultrasound solution designed for versatility, durability, and superior imaging in diverse clinical environments. It balances console-quality imaging with true portability, featuring a lightweight magnesium casing and an extended battery life of up to 7.5 hours. The system integrates advanced imaging technologies like ClearVision, HQ-Vision, and S-Harmonic to deliver clear, uniform, high-resolution 2D and color images, enhancing diagnostic confidence. Optimized workflow features such as QuickPreset, EzExam+, and EzAssist streamline examinations and improve operational efficiency. The HM70 EVO supports a wide range of clinical applications and patient types, making it suitable for hospitals, private practices, and mobile clinics. Notably, recent FDA clearance indicates the inclusion of AI-based software functions like NerveTrack and UterineAssist, further enhancing its diagnostic capabilities.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Portable and lightweight design with magnesium casing
  • Extended battery life (up to 7.5 hours)
  • Advanced imaging technologies: ClearVision, HQ-Vision, S-Harmonic, S-Flow, SDMR
  • Streamlined workflow with QuickPreset, EzExam+, and EzAssist
  • Support for 2D, Color Doppler, Power Doppler, M-Mode, Pulsed Wave, TDI, TDW
  • 3D/4D imaging capabilities with RealisticVue(Lite) and Smart Filter Volume Imaging
  • AI-based functions: NerveTrack and UterineAssist
  • Comprehensive transducer support (10 compatible transducers)
  • DICOM 3.0 connectivity for image storage and worklist management
  • Cybersecurity features including Windows 10, BitLocker, and DICOM TLS

Use Cases

  • Cardiac ultrasound
  • Abdominal and emergency imaging (FAST exams)
  • Vascular and musculoskeletal examinations
  • OB-GYN applications (including 4D obstetric imaging)
  • Small parts and breast imaging
  • Urology, pediatrics, and neonatal cephalic imaging

What Physicians Need to Know

DICOM Support & Standards
The HM70 EVO supports DICOM 3.0, including Storage, Worklist, Structured Report (SR), Performed Procedure Step (PPS), Storage Commitment (SC), and Print services. It also features secure (TLS) DICOM transmission.
PACS Integration Method
The system facilitates seamless integration with Picture Archiving and Communication Systems (PACS) through its comprehensive DICOM support. It can transfer images to a PACS server and supports DICOM Modality Worklist for efficient patient information search and management. Connectivity options include Ethernet and optional WiFi.
Reading Room Workflow Impact
Designed for a streamlined and efficient workflow, the HM70 EVO incorporates features like QuickPreset for instant recall of customized settings, EzExam+ for guided examination protocols, and EzAssist for automated measurements. Its intuitive interface, full-screen mode, and portability (with up to 7.5 hours of battery life with an extended pack) enhance operational efficiency in various clinical environments.
AI Model Architecture (deep learning approach)
The HM70 EVO integrates 'AI-like tools' or intelligent assistance features rather than explicit deep learning models for diagnostic interpretation. Key features include BiometryAssistu2122 for automated fetal biometry measurements and QuickScanu2122 for real-time automatic optimization of 2D/Doppler settings. EzExam+u2122 also provides protocol guidance to ensure complete examinations.
FDA Clearance Pathway (510k/De Novo)
The HM70 EVO Diagnostic Ultrasound System received 510(k) Premarket Notification clearance (K210713) from the FDA on July 9, 2021, indicating substantial equivalence to predicate devices.
Supported Modalities (CT/MRI/X-ray/US)
The HM70 EVO is a dedicated Diagnostic Ultrasound (US) system. It supports a wide range of ultrasound applications, including Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel, and Lung imaging.
Physician Tip

Leverage the HM70 EVO's portability and extended battery life for point-of-care diagnostics and mobile clinics, enhancing patient access and workflow flexibility. Utilize QuickPreset and EzExam+ to standardize examination protocols, reduce variability, and improve efficiency, especially in high-throughput or emergency settings. While not a standalone diagnostic AI, the BiometryAssistu2122 and QuickScanu2122 features can significantly reduce manual steps and optimize image quality, allowing for more focused patient interaction and diagnostic confidence. Ensure staff are trained on these intelligent assistance tools to maximize their benefits in daily practice.

The HM70 EVO offers robust DICOM 3.0 compliance, enabling seamless integration with existing PACS for image archiving, retrieval, and worklist management. Its support for secure DICOM transmission (TLS) is crucial for maintaining data security and patient privacy within the hospital network. The system's Ethernet and optional WiFi connectivity further facilitate network integration, allowing for efficient data transfer and communication within a digital radiology ecosystem. Consider leveraging its DICOM SR capabilities for structured reporting to enhance data consistency and interoperability with EMR/EHR systems.

Details

Category Radiology & Imaging AI
Pricing Paid, one-time purchase — New units from $23,575; Refurbished units from $24,575 to $29,375
DeploymentOn-premise
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The HM70 EVO Diagnostic Ultrasound System has received multiple FDA 510(k) clearances, with the latest on December 21, 2023 (K233112). This clearance included new software functions, NerveTrack and UterineAssist, which are based on AI technology.

Integrations
EHR Not specified
Specialties Emergency Medicine, Obstetrics & Gynecology, Radiology

What the Web Says

The Samsung HM70 EVO Diagnostic Ultrasound System is a highly regarded portable, mid-range ultrasound machine praised for its versatility, advanced imaging capabilities, and robust design. It's often considered an upgrade from earlier portable systems and is suitable for a wide range of clinical applications, particularly excelling in emergency medicine, musculoskeletal (MSK), and superficial imaging, as well as 4D obstetric imaging.

Overall: Positive

Strengths

  • Excellent image quality, including clear, uniform, high-resolution 2D and color Doppler imaging.
  • Strong 4D capabilities, considered among the best portable systems for obstetric 4D imaging.
  • Versatile for a wide range of clinical applications and patient types, including general imaging, internal medicine, OB/GYN, cardiology, neurology, pediatrics, urology, MSK, breast, small parts, and emergency medicine.
  • Portable, compact, and robust design with magnesium casing and enhanced battery life (up to 7.5 hours), ideal for point-of-care, mobile, or bedside use.
  • Efficient workflow with features like EzExam+, QuickExam, and QuickSave, and intuitive interfaces.
  • Advanced technology integration such as S-Harmonic, S-Flow, Needle Mate, ClearVision, HQ-Vision, and SDMR for enhanced diagnostic confidence and image optimization.

Limitations

  • More expensive than basic handheld units.
  • Capable but not ideal for high-end cardiac practices, as specialized cardiac systems may offer superior features.
  • Usually has only one active probe port, which may slow workflow if frequent transducer switching is required.
  • Less ideal for gynecological use compared to some competitors, where higher image quality is prioritized over speed.
  • External CD/DVD-R needed for some data export functions.
  • Some minor ergonomic improvements could be made.

Based on reviews from: Lepeke Medical, Marcroft Medical, FOVU, Reddit, Samsung Healthcare USA, Choice Medical Systems, Strata Imaging, UDS, YouTube, Probo Medical

Last updated: 2026-07-20

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Press & Coverage

X-ray Interpreter
HM70 EVO Diagnostic Ultrasound System | FDA Radiology AI Device - X-ray Interpreter
The HM70 EVO Diagnostic Ultrasound System by Samsung Medison is a mobile, software-controlled ultrasound imaging device that received FDA approval on December 21, 2023. It captures detailed 2D, 3D, and Doppler ultrasound images across various clinical applications and includes AI-powered features for nerve detection and uterus assistance.
2023-12
FDA
510(k) Premarket Notification - FDA
This is a 510(k) Premarket Notification for the HM70 EVO Diagnostic Ultrasound System from Samsung Medison Co., Ltd., with the latest update on June 8, 2026, detailing regulatory information and contact persons.
2026-06
accessdata.fda.gov
December 21, 2023 Samsung Medison CO., LTD. So-Yeon Jang Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon- - accessdata.fda.gov
This FDA document from December 21, 2023, details the substantial equivalence determination for the HM70 EVO Diagnostic Ultrasound System, comparing it to predicate devices and outlining its intended use, imaging capabilities, and safety performance.
2023-12
X-ray Interpreter
Samsung Medison | Radiology AI Companies - X-ray Interpreter
This article highlights the HM70 EVO Diagnostic Ultrasound System as one of Samsung Medison's products, noting its FDA release on December 21, 2023, and its advanced AI-powered features for improved diagnostic accuracy.
2023-12
GlobalData
Ultrasound Systems Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies - GlobalData
A February 2024 report on the Ultrasound Systems Pipeline mentions Samsung Medison receiving additional 510(k) clearance for the HM70 EVO Diagnostic Ultrasound System on January 4, 2024, indicating ongoing regulatory activity and product development.
2024-02
PMC (PubMed Central)
Cardiovascular Functioning Features in Individuals with Connective Tissue Dysplasia Engaged in Sports for the Disabled - PMC
This peer-reviewed article describes the use of a u201cSamsung HM70 EVOu201d diagnostic ultrasound system for transthoracic echocardiography (TTE) in a study on cardiovascular functioning in individuals with connective tissue dysplasia engaged in sports for the disabled.
unknown
accessdata.fda.gov
December 10, 2024 Samsung Medison Co., Ltd. So-Yeon Jang Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, - accessdata.fda.gov
An FDA document from December 10, 2024, references the HM70 EVO Diagnostic Ultrasound System (K233112) in a 510(k) summary for other Samsung Medison ultrasound systems, indicating its role as a predicate device for newer models.
2024-12

Videos

Product demos, reviews, and walkthroughs for HM70 EVO Diagnostic Ultrasound System.

View all on YouTube

Frequently Asked Questions

The HM70 EVO incorporates AI-driven features such as BiometryAssistu2122 for automated fetal measurements, AutoIMT+u2122 for carotid intima-media thickness, and EzExam+u2122 for guided protocols, which streamline workflow and enhance measurement consistency. It also includes QuickScanu2122 for real-time 2D/Doppler optimization and features like NerveTrack and UterineAssist to aid in various examinations.
The HM70 EVO operates on Windows 10 and includes robust security features like BitLocker SSD encryption, audit trails, and password control, along with secure (TLS) DICOM transmission to protect patient data. Samsung adheres to stringent cybersecurity requirements, including the DoD's Risk Management Framework (RMF) and the CIA triad (Confidentiality, Integrity, and Availability), and its Quality System complies with ISO 13485:2016.
The HM70 EVO ultrasound system has received FDA 510(k) clearance for diagnostic imaging. Specific AI features like NerveTrack and UterineAssist, integrated into the HM70 EVO, were previously cleared in other Samsung ultrasound systems, such as the V8.
The AI capabilities in the HM70 EVO are designed to augment physician judgment by automating routine measurements and optimizing image quality, thereby improving efficiency and reproducibility. However, these features serve as assistive tools, and a physician's diagnostic expertise remains paramount; some advanced imaging features may also be optional extras, and the system's maximum depth range of approximately 38 cm might limit very deep imaging.
The HM70 EVO is designed with a streamlined workflow and intuitive interfaces, including features like EzExam+u2122 for guided protocols, aimed at minimizing the learning curve and maximizing productivity. It supports DICOM for seamless integration with EMR systems and offers quick image export via USB.
The HM70 EVO offers AI-driven automation for specific applications like OB/GYN and vascular imaging. While it provides strong performance, other leading portable and handheld systems from manufacturers such as GE, Philips, Mindray, and Butterfly iQ3 also offer various AI capabilities, some with advanced features for image analysis and workflow enhancement.
The average cost for a new HM70 EVO Portable is around $16,722, with prices varying based on configuration and vendor. While core AI-like automation features are integrated, some advanced functionalities such as 3D/4D, RealisticVue, or extended Doppler options may be considered optional extras or require additional licensing, which should be confirmed with the vendor.

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