EdgeFlow UH10

by Edgecare Inc.  · Based in South Korea → — Simplifying Healthcare for All
Emergency Medicine Radiology Urology

Contact vendor for pricing information.
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, ±7.5% 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 available information does not specify DICOM support or standards for the EdgeFlow UH10. It is a bladder scanner that utilizes ultrasound imaging and AI for bladder volume measurement.
PACS Integration Method
The available information does not specify PACS integration methods for the EdgeFlow UH10. It does mention data export via Wi-Fi and USB.
Reading Room Workflow Impact
The EdgeFlow UH10 is designed to simplify bladder scanning and optimize workflow. Its intuitive user interface, lightweight and ergonomic design, and fast, accurate bladder volume measurements aim to improve diagnostic efficiency and patient care. The device can streamline EMR charting with barcode-based data entry.
AI Model Architecture (deep learning approach)
The EdgeFlow UH10 is powered by deep learning technology. It incorporates LiveContour™ and MaxContour™ technologies, which are deep learning AI-powered functionalities. LiveContour™ automatically identifies the bladder's contour in real-time ultrasound images, while MaxContour™ optimizes image selection for consistent measurements. The deep learning algorithm performs automated bladder segmentation and volume estimation.
Processing Speed (per study)
The EdgeFlow UH10 is designed for quick, accurate, and noninvasive bladder volume measurement with a single scan. It aims to provide fast calculations of accurate measurement values.
FDA Clearance Pathway (510k/De Novo)
The EdgeFlow UH10 received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on March 7, 2024.
Supported Modalities (CT/MRI/X-ray/US)
The EdgeFlow UH10 is an ultrasound bladder scanner. It utilizes high-resolution ultrasound imaging. The device supports both B-mode and harmonic imaging.
Sensitivity & Specificity Data
The EdgeFlow UH10 has a volume measurement range of 0 to 999 mL, with an accuracy of ±7.5 mL for volumes 0-100 mL and ±7.5% for volumes over 100 mL.
RSNA/ACR Validation
The available information does not mention specific RSNA/ACR validation for the EdgeFlow UH10. Edgecare plans to participate in the American Urological Association (AUA) Annual Meeting in May 2024.
Physician Tip

The EdgeFlow UH10 offers a user-friendly experience with its intuitive interface and ergonomic design, making it suitable for various clinical settings. Its deep learning-based AI, including LiveContour™ and MaxContour™ technologies, assists in accurate bladder identification and volume measurement, potentially reducing the learning curve for new users. The DualActive™ probe allows for simultaneous viewing of sagittal and transverse planes, which can enhance confidence in bladder localization and measurement. The device's portability and quick scan capabilities can significantly streamline workflow for bladder assessments. Consider its accuracy specifications (±7.5 mL for 0-100 mL and ±7.5% for >100 mL) when interpreting results, especially for critical measurements. The barcode-based charting feature can help integrate the device into existing EMR systems.

The EdgeFlow UH10 supports data export via Wi-Fi and USB connections. It also features barcode-based charting for streamlined EMR integration. The device comes with a dual-function cradle station for charging and printing results.

Details

Category Radiology & Imaging AI
Pricing Contact vendor for pricing information.
DeploymentOn-premise
Data ExportUnknown
TrainingUnknown
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Emergency Medicine, Radiology, Urology

Support & Reliability

Training ProvidedUnknown

What the Web Says

The EdgeFlow UH10 is a handheld ultrasound bladder scanner designed for quick, accurate, and non-invasive bladder volume measurement. It utilizes deep learning AI for bladder detection, outlining, and volume calculation, displaying results on a touchscreen. The device has received FDA clearance and is marketed in various regions, including the United States and South Korea.

Overall: Positive

Strengths

  • Quick, accurate, and non-invasive bladder volume measurement.
  • Utilizes deep learning AI for intelligent and user-friendly experience, including LiveContour™ for real-time bladder contour identification and MaxContour™ for automatic selection of the largest image for accurate measurements.
  • DualActive™ probe delivers high-resolution sagittal and transverse bladder images simultaneously, eliminating the need to rotate the probe.
  • Ergonomic, lightweight (419g console & probe), and easy-to-grip design with an intuitive user interface.
  • Dual-function cradle station for charging and printing results, with advanced data management including barcode scanning and data export via Wi-Fi and USB.
  • FDA cleared.

Limitations

  • Limited independent user reviews from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found.
  • One study using the device for AI-based bladder volume estimation was conducted using only tissue-mimicking phantoms, not human subjects.
  • Specific details on long-term reliability and customer support experiences are not readily available in the search results.

Based on reviews from: uscimaging.com, nih.gov, mdpi.com, fda.gov, healthaidb.com, urologytimes.com, ultrasoundportables.com, edgecare.co.kr, youtube.com, medica.de, dgu-serviceforum.de, europages.fr, researchgate.net

Last updated: 2026-10-29

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Press & Coverage

edgecare.co.kr
Edgecare Inc. Obtains U.S. FDA Clearance for Ultrasound Bladder Scanner EdgeFlow UH10
Edgecare announced on March 7, 2024, that its EdgeFlow UH10 bladder scanner received U.S. FDA 510(k) clearance, confirming its safety and effectiveness for non-invasive bladder volume measurement and paving the way for expansion into U.S. and global markets.
2024-03
urologytimes.com
EdgeFlow UH10 Bladder Scanner Receives FDA 510(k) Clearance
The FDA granted 510(k) clearance to the EdgeFlow UH10 ultrasound bladder scanner, which uses high-resolution ultrasound imaging to non-invasively measure post-void residual urine in the bladder.
2024-03
edgecare.co.kr
Edgecare Showcases EdgeFlow UH10 Bladder Scanner at Arab Health 2024
Edgecare successfully showcased its EdgeFlow UH10 Bladder Scanner at Arab Health 2024 in Dubai, introducing the device to a global audience and engaging with international buyers and industry stakeholders.
2024-02
edgecare.co.kr
Edgecare's EdgeFlow UH10 Achieves CE Marking Under EU MDR, Driving Global Market Expansion
Edgecare announced on January 9, 2025, that its EdgeFlow UH10 ultrasound bladder scanner achieved CE Marking under EU MDR, which is expected to drive global market expansion.
2025-01
mdpi.com
FDA-Authorized Machine Learning-Enabled Medical Devices in 2024
A cross-sectional analysis of FDA-authorized ML-enabled medical devices in 2024 mentions EdgeFlow UH10 (K231677) as a 510(k) cleared device utilizing neural networks.
2025-12
edgecare.co.kr
Edgecare Selected as an Innovative Medical Device Company by the Ministry of Health and Welfare
Edgecare was selected as an Innovative Medical Device Company by the Ministry of Health and Welfare on January 5, 2026, recognizing its technological innovation and potential in the medical device industry, particularly for its patch-based ultrasound monitoring technology.
2026-01
urologywatch.com
EdgeFlow UH10 Bladder Scanner: FDA status, noninvasive measurement of postvoid residual ur | UrologyWatch
The EdgeFlow UH10 Bladder Scanner received FDA 510(k) clearance on March 7, 2024, for the noninvasive measurement of postvoid residual urine in the bladder.
2024-03
ultrasoundportables.com
Portable Ultrasound Accuracy
A literature review in the journal Diagnostics, which included the EdgeFlow UH10 Bladder Scanner, found that portable ultrasounds are generally accurate for various medical applications, often comparable to high-end ultrasound systems.
unknown

Videos

Product demos, reviews, and walkthroughs for EdgeFlow UH10.

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Frequently Asked Questions

The EdgeFlow UH10 is an ultrasound bladder scanner that uses AI, specifically deep learning technology, to non-invasively measure bladder volume. It incorporates LiveContour™ and MaxContour™ technologies to automatically identify and optimize the bladder's contour in real-time ultrasound images, aiding in accurate volume assessment.
The EdgeFlow UH10 has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), affirming its safety and effectiveness for non-invasive measurement of post-void residual urine in the bladder. It also complies with other standards such as HIPAA, ISO 13485, and various IEC 60601 series for medical devices.
The EdgeFlow UH10 is specifically designed for bladder volume measurement, differentiating it from broader radiology AI solutions that focus on acute triage, finding detection, or reporting. Its unique selling points include its DualActive™ probe for simultaneous sagittal and transverse views, deep learning-based LiveContour™ and MaxContour™ technologies for accurate bladder identification, and its portable, ergonomic design. It offers a focused solution for urology and nephrology specialties.
The EdgeFlow UH10 is available for purchase, with prices starting at approximately $5500. While some sources indicate a subscription pricing model, it's best to contact the vendor directly for the most accurate and current pricing information, including any volume discounts.
While highly accurate for bladder volume measurement, the EdgeFlow UH10 is a specialized device. Its primary limitation is its specific application to bladder scanning, meaning it is not a general-purpose radiology AI tool for broader diagnostic imaging. Images are for marketing use only and not for medical interpretation; users should refer to the manual for proper use.

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