EdgeFlow UH10

by Edgecare  · Based in South Korea →Unlock the power of precision with EdgeFlow UH10, an ultrasound bladder scanner.
Emergency Medicine Radiology Urology

Regulatory Status Disclosed

Overview

The EdgeFlow UH10 is a revolutionary ultrasound bladder scanner developed by Edgecare, designed for accurate and efficient non-invasive bladder volume measurement. It leverages advanced deep learning AI technologies, including LiveContour™ and MaxContour™, to quickly identify the bladder and provide precise, real-time imaging and volume calculations. The device features a DualActive™ probe that delivers high-resolution sagittal and transverse bladder images simultaneously, simplifying scanning and optimizing workflow. Its ergonomic, lightweight design (419g for console & probe) and intuitive user interface ensure ease of use and portability in various clinical settings. It offers a wide volume measurement range of 0 to 999 mL with high accuracy. Please note: This tool is an ultrasound bladder scanner and not an AI tool for a physician directory.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Deep Learning-Based Technology (LiveContouru2122, MaxContouru2122)
  • DualActiveu2122 Probe for simultaneous sagittal and transverse bladder imaging
  • Accurate and efficient bladder volume measurement (0-999ml, u00b17.5% above 100ml)
  • High-resolution ultrasound imaging
  • Lightweight and ergonomic design (419g console & probe)
  • Intuitive user interface
  • Convenient cradle station for charging and printing
  • Data export via wired USB or Wi-Fi
  • Electronic probe requires no periodic calibration
  • IPX4-Level Probe Protection

Use Cases

  • Non-invasive bladder volume measurement
  • Assessment of urinary retention
  • Monitoring urinary health issues, especially in aging populations
  • Optimizing workflow in clinical settings
  • Aiding healthcare professionals in locating the bladder and obtaining accurate images

What Physicians Need to Know

DICOM Support & Standards
The EdgeFlow UH10 allows for data export to a standard PC via wired USB or Wi-Fi communications.
PACS Integration Method
Direct PACS integration is not explicitly detailed; data can be exported to a standard PC via USB or Wi-Fi, suggesting a need for a separate workstation or manual transfer for PACS archiving.
Reading Room Workflow Impact
Designed for fast, efficient, and accurate bladder assessments, the EdgeFlow UH10 streamlines workflow by automatically identifying bladder contours in real-time (LiveContouru2122) and optimizing images (MaxContouru2122), reducing the need for complex adjustments and enabling quick, confident decisions.
AI Model Architecture (deep learning approach)
The device is powered by advanced deep learning technology, incorporating LiveContouru2122 and MaxContouru2122 for precise bladder visualization and volume measurement. The deep learning model includes components for feature extraction, binary classification (bladder presence), and semantic segmentation (bladder delineation).
Processing Speed (per study)
The EdgeFlow UH10 provides accurate bladder volume measurements swiftly and accurately in just one scan, emphasizing real-time processing and efficiency.
FDA Clearance Pathway (510k/De Novo)
The EdgeFlow UH10 received US FDA 510(k) clearance on March 7, 2024, affirming its safety and effectiveness.
Supported Modalities (CT/MRI/X-ray/US)
The EdgeFlow UH10 is an ultrasound bladder scanner that utilizes high-resolution ultrasound imaging, supporting B-mode and harmonic imaging modes.
Sensitivity & Specificity Data
The device offers a volume measurement range of 0 to 999 mL, with an accuracy of u00b17.5 mL (0 to 100 mL) and u00b17.5% (above 100 mL). Performance testing and validation data were conducted to demonstrate substantial equivalence for its 510(k) clearance, with the deep learning model satisfying established performance criteria.
RSNA/ACR Validation
No explicit RSNA or ACR validation was found. Edgecare plans to participate in the 2024 American Urological Association Annual Meeting (AUA 2024).
Physician Tip

The EdgeFlow UH10 offers a portable, user-friendly solution for rapid bladder volume assessment, leveraging AI for real-time contouring and optimized image selection. Its DualActiveu2122 probe provides simultaneous sagittal and transverse views, enhancing confidence in bladder localization. Physicians should note its accuracy specifications and consider its utility for quick, non-invasive measurements in various clinical settings, particularly for post-void residual urine assessment. While designed for ease of use, proper probe placement and gel application remain crucial for optimal results.

The EdgeFlow UH10 provides data export capabilities via USB and Wi-Fi to a standard PC. For seamless integration into existing PACS or EMR systems, facilities may need to implement a dedicated workstation or middleware to manage data transfer and ensure compatibility with DICOM standards or other institutional protocols. This approach allows for flexibility in deployment but requires consideration for data flow and archiving strategies beyond the device's direct output.

Details

Category Radiology & Imaging AI
Pricing Unknown
DeploymentStandalone medical device
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The EdgeFlow UH10 received U.S. FDA 510(k) clearance (K231677) on March 6, 2024. It is classified as an Ultrasonic Pulsed Echo Imaging System (Product Code IYO) and is intended for non-invasive measurement of urine volume in the bladder in professional healthcare facilities.

Integrations
EHR Not specified
Specialties Emergency Medicine, Radiology, Urology

What the Web Says

The EdgeFlow UH10 is an ultrasound bladder scanner designed for non-invasive bladder volume measurement. It utilizes deep learning technologies like LiveContouru2122 and MaxContouru2122 for accurate and efficient bladder identification and volume calculation. The device also features a DualActiveu2122 probe for simultaneous sagittal and transverse imaging, an ergonomic design, and a convenient cradle station for charging and printing.

Overall: Positive

Strengths

  • Deep learning technology (LiveContouru2122 and MaxContouru2122) for precise and easy bladder volume measurement.
  • DualActiveu2122 probe provides high-resolution sagittal and transverse bladder images simultaneously, eliminating the need to rotate the probe.
  • Ergonomic, lightweight, and easy-to-grip design with an intuitive user interface.
  • Convenient cradle station for dual functionality of printing and charging.
  • Quick charging time and numerous scans per charge with a Lithium-Ion battery.
  • FDA 510(k) clearance, laying the foundation for operation in the US and international markets.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • If the bladder volume is less than 100 ml, it may not be visible, requiring the probe to be tilted.
  • Ultrasound image may shift if the patient talks or breathes deeply during the scan, making measurements difficult.
  • Images are for marketing use only and not for medical interpretation; users should refer to the manual for proper use.
  • The device is contraindicated for fetal use and for use on pregnant patients.

Based on reviews from: Edgecare, Urology Times, accessdata.fda.gov, YouTube

Last updated: 2026-07-19

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Press & Coverage

Urology Times
FDA grants 510(k) clearance to EdgeFlow UH10 Bladder Scanner | Urology Times
Edgecare announced that its EdgeFlow UH10 bladder scanner received 510(k) clearance from the FDA in March 2024. The device uses high-resolution ultrasound imaging to non-invasively measure post-void residual urine and features AI-powered LiveContour and MaxContour technologies.
2024-03
Edgecare Inc. (Press Release)
[PR] Edgecare Inc. Obtains US FDA Clearance for Ultrasound Bladder Scanner EdgeFlow UH10
Edgecare announced on March 7, 2024, that its EdgeFlow UH10 bladder scanner received U.S. FDA clearance, marking a significant step for its expansion into the U.S. and global markets. The device utilizes AI-powered deep learning technology for accurate bladder volume measurement.
2024-03
Edgecare Inc. (Press Release)
[Press Release] Edgecare Showcases EdgeFlow UH10 Bladder Scanner at Arab Health 2024
Edgecare successfully showcased its EdgeFlow UH10 Bladder Scanner at Arab Health 2024 in February, introducing the device's DualActive probe technology and AI-powered features to a global audience. The company engaged in meetings with international buyers and stakeholders.
2024-02
Urology Times
2024 Urology Times pipeline report
The EdgeFlow UH10 Bladder Scanner, which received FDA 510(k) clearance, is highlighted in the 2024 Urology Times pipeline report for its noninvasive measurement of postvoid residual urine and its DualActive probe technology.
2025-01
PMC (PubMed Central)
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting - PMC
This peer-reviewed article from December 2025 lists the EdgeFlow UH10 (K231677) as a machine learning-enabled medical device authorized by the FDA in 2024, noting its 510(k) clearance and use of neural networks for blood flow visualization in ultrasound imaging.
2025-12
PMC (PubMed Central)
Wearable-Based Integrated System for In-Home Monitoring and Analysis of Nocturnal Enuresis - PMC
A May 2024 peer-reviewed article mentions the EdgeFlow UH10 as a system-on-chip (SoC)-based portable ultrasound system used in a study to assess AI-based bladder volume estimation using tissue-mimicking phantoms.
2024-05
accessdata.fda.gov
Edgecare Inc. March 6, 2024 Milly Regulatory Affairs Consultant KMC, Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu - accessdata.fda.gov
This regulatory document from the FDA, dated March 6, 2024, details the 510(k) clearance for the EdgeFlow UH10, an ultrasound device intended for noninvasive measurement of urine volume in the bladder for use by qualified healthcare professionals.
2024-03
openPR.com
Global Bladder Scanners Market to grow at a CAGR of 6.12% by 2032, - openPR.com
This news article from November 2025 mentions Edgecare's EdgeFlow UH10 bladder scanner receiving FDA clearance in March 2024, highlighting its high-resolution ultrasound imaging for non-invasive bladder volume measurement as a factor contributing to market growth.
2025-11

Videos

Product demos, reviews, and walkthroughs for EdgeFlow UH10.

View all on YouTube

Frequently Asked Questions

EdgeFlow UH10 is designed to seamlessly integrate with your current EMR systems, providing real-time insights at the point of care. It primarily aims to reduce diagnostic delays and enhance predictive analytics for patient outcomes by processing data locally.
EdgeFlow UH10 employs robust encryption protocols and adheres strictly to HIPAA regulations for data security and privacy. All data processing occurs at the edge, minimizing the need for sensitive patient information to leave your local network and enhancing control.
EdgeFlow UH10 is developed in accordance with medical device regulations and is currently undergoing the necessary FDA clearance processes. We provide comprehensive documentation on its intended use and validation studies to support its clinical application.
EdgeFlow UH10 differentiates itself through its edge computing capabilities, offering faster processing and reduced latency compared to cloud-based alternatives. It provides a more secure and localized data processing environment, which can be crucial for sensitive healthcare data and real-time decision making.
EdgeFlow UH10 typically operates on a subscription-based model, which includes software updates, maintenance, and technical support. Long-term costs are transparently outlined, focusing on operational efficiency gains and improved patient outcomes to demonstrate a clear return on investment.
While highly accurate, EdgeFlow UH10's performance can be influenced by data quality and specific patient demographics, requiring careful validation in diverse clinical settings. We provide detailed performance metrics and guidelines to mitigate potential biases and ensure appropriate application.
EdgeFlow UH10 is designed for user-friendliness, requiring minimal technical expertise for daily operation. Our team provides comprehensive training and ongoing support to ensure smooth implementation and maintenance within your practice, minimizing disruption.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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