VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

by Vuno  · Based in South Korea →Prioritize urgent cases & improve accuracy
Critical Care Emergency Medicine Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is an AI-based software solution designed to analyze adult chest X-ray images for the rapid detection of critical conditions such as pleural effusion and pneumothorax. This radiological computer-assisted triage and notification software utilizes a convolutional neural network (CNN) based deep learning algorithm to identify features suggestive of these critical findings. It provides case-level output for worklist prioritization or triage within a radiologist’s PACS or workstation, delivering passive notifications without marking the original images. The software is intended to assist healthcare professionals in managing urgent cases efficiently by providing rapid automated classification results, contributing to faster treatment in emergency rooms and other medical settings. It supports DICOM, JPG, and PNG image formats and is designed to integrate seamlessly into standard reading environments. The device achieved high performance with ROC AUC > 0.95 and sensitivity/specificity above 95% for both conditions, with notification timing under 10 seconds.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based analysis of adult chest X-ray images
  • Detection of pleural effusion and pneumothorax
  • Prioritizes urgent cases in clinical workflow
  • Provides passive notifications in PACS/workstation
  • Supports DICOM, JPG, and PNG image formats
  • Utilizes Convolutional Neural Network (CNN) based deep learning algorithm
  • High diagnostic performance (ROC AUC > 0.95, sensitivity/specificity > 95%)
  • Rapid notification timing (under 10 seconds)
  • Vendor agnostic algorithm
  • Integration with PACS and EMR systems

Use Cases

  • Rapid screening for critical conditions in emergency rooms
  • Prioritizing radiologist worklists for urgent cases
  • Assisting healthcare providers in efficient case management
  • Diagnostic support for major pulmonary diseases
  • Reducing chest X-ray reading time
  • Improving accuracy of X-ray interpretations

What Physicians Need to Know

DICOM Support & Standards
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage utilizes a vendor-agnostic algorithm compatible with DICOM chest X-ray images, allowing data transmission via the DICOM protocol.
PACS Integration Method
The solution is integrated with PACS, providing case-level output for worklist prioritization or triage directly within the PACS/workstation. It offers cloud-based service options, can be embedded into X-ray devices, and provides APIs for flexible integration into user reading system settings.
Reading Room Workflow Impact
This AI tool acts as a radiological computer-assisted triage and notification software, analyzing adult chest X-ray images for suspected pleural effusion and/or pneumothorax to prioritize urgent cases. It offers passive notification within the standard workflow, aiming to provide rapid automated classification results for faster treatment, especially in emergency settings, and to improve reading efficiency and accuracy. It is not intended for stand-alone clinical decision-making.
AI Model Architecture
The AI model is based on a convolutional neural network (CNN), employing deep learning technology. It was trained on tens of thousands of chest PA X-ray images from multiple sites in South Korea and India, encompassing data from over 13 different modality manufacturers. The algorithm is 'locked' to ensure consistent results.
Processing Speed (per study)
The average time for displaying results is below 10 seconds, enabling instant detection and flagging of suspected abnormalities directly upon image scanning.
FDA Clearance Pathway
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage received 510(k) Clearance (K241439) from the U.S. FDA, classified as a Class II radiological computer-aided triage and notification software (21 CFR 892.2080, QFM).
Supported Modalities
The tool is specifically designed to analyze adult chest X-ray images.
Sensitivity & Specificity Data
The Area Under the Curve (AUC) for triaging scans suspicious of pneumothorax and pleural effusion exceeded the acceptance criteria for FDA 510(k) clearance. The system focuses on detecting these critical findings for triage purposes.
RSNA/ACR Validation
The underlying deep learning models have been presented at the RSNA 2019 Scientific Assembly and Annual Meeting. VUNO also officially launched and promoted its FDA-cleared VUNO Med-Chest X-ray Triage at RSNA 2024.
Physician Tip

This AI tool is designed for rapid triage and prioritization of chest X-ray images, specifically highlighting suspected pleural effusion and/or pneumothorax. It provides passive notifications to aid in worklist management and should not be used as a standalone diagnostic tool. Radiologists and healthcare professionals retain responsibility for final clinical decisions. Its quick processing and intuitive visualizations can be particularly beneficial in high-volume settings like emergency rooms, helping to efficiently identify and manage urgent cases.

VUNO Med-Chest X-ray Triage offers flexible integration options, supporting DICOM standards for seamless connectivity with existing PACS and workstations. It can be deployed as a cloud-based service or directly embedded into X-ray devices. The availability of APIs further facilitates its integration into diverse user reading systems and clinical workflows, maximizing user convenience and operational efficiency.

Details

Category Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Contact for pricing Not specified
DeploymentCloud-based, On-premise, PACS integration
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage received FDA 510(k) clearance (K241439) on November 15, 2024. It is cleared as a radiological computer-assisted triage and notification software for detecting suspected critical findings (pleural effusion and/or pneumothorax) in adult chest X-ray images.

Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, Radiology

What the Web Says

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is an AI-powered radiological computer-assisted triage and notification software designed to analyze adult chest X-ray images for suspected critical findings like pleural effusion and pneumothorax. It aims to provide rapid automated classification results to healthcare providers, potentially leading to faster treatment in emergency rooms and other medical settings. The software integrates with existing PACS/workstation systems to prioritize worklists based on its analysis, but it does not send proactive alerts directly to specialists or make standalone clinical decisions.

Overall: Positive

Strengths

  • Analyzes chest X-ray images for critical findings such as pneumothorax and pleural effusion.
  • Provides rapid automated classification results, potentially speeding up treatment in emergency settings.
  • Uses an AI algorithm (convolutional neural network) trained on a large dataset of chest X-ray images.
  • Compatible with DICOM chest X-ray images and vendor-agnostic.
  • Offers seamless integration with existing reading systems (PACS) and can be cloud-based or on-premise.
  • Received FDA 510(k) clearance and CE certification.

Limitations

  • Not intended to direct attention to specific portions of an image or anomalies other than pleural effusion and/or pneumothorax.
  • Results are not intended to be used on a stand-alone basis for clinical decision-making.
  • Does not send proactive alerts directly to medical specialists; it's a passive notification tool for prioritization.
  • General chest X-rays have limitations in diagnosing certain conditions like lung cancer and COVID-19, which could indirectly affect the perceived utility of AI tools based on them.
  • Some AI models for chest X-rays have shown disparities in accuracy across different demographics, particularly for women and Black people.

Based on reviews from: accessdata.fda.gov, KBR (Korea Biomedical Review), Health AI Register, App Commons, VUNO (vuno.co), AuntMinnie, PR Newswire, MedTech Innovator, Reddit

Last updated: 2026-07-19

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Press & Coverage

KBR (Korea Biomedical Review)
VUNO's AI-driven chest X-ray triage solution scores FDA nod
VUNO announced that its AI-based chest X-ray reading assistant solution, VUNO Med-Chest X-ray Triage, received 510(k) Clearance from the U.S. FDA. The solution quickly screens for pneumothorax and pleural effusion, aiming to provide rapid automated classification results for faster treatment in emergency settings.
2024-11
U.S. Food & Drug Administration (FDA)
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage 510(k) Premarket Notification
This regulatory document details the FDA's 510(k) clearance for VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage, classifying it as a radiological computer-assisted triage and notification software for analyzing adult chest X-ray images for suspected critical findings like pleural effusion and pneumothorax.
2024-11
KBR (Korea Biomedical Review)
VUNO to showcase FDA-cleared AI solutions at RSNA 2024
VUNO plans to officially launch and promote its FDA 510(k) cleared VUNO Med-Chest X-ray Triage at RSNA 2024, an AI solution designed to quickly detect pneumothorax and pleural effusion from chest X-rays. The company aims to expand into overseas markets through partnerships with medical institutions.
2024-11
Signify Research
AI in Medical Imaging News Round Up u2013 November 2024
VUNO Inc. received FDA clearance for VUNO Medu2013Chest X-ray Triage, a solution for the detection of pneumothorax and pleural effusion, as part of a broader trend of regulatory approvals in AI in medical imaging during November 2024.
2024-12
KBR (Korea Biomedical Review)
VUNO to issue $18 mil. in bonds for US expansion, R&D
VUNO announced plans to issue $18 million in bonds to fund its U.S. market expansion and R&D efforts, following FDA approvals for VUNO Med-DeepBrain in October and VUNO Med-Chest X-ray Triage in November.
2024-12
kormedi.com
FDA Approved VUNO's AI Chest X-ray Diagnostic Device
VUNO's AI-based chest X-ray diagnostic device, VUNO Med-Chest X-ray Triage, received FDA approval, enabling rapid detection and categorization of pneumothorax and pleural effusion to enhance emergency response times.
2024-11
VUNO Official Website
Our History
VUNO's history page highlights key milestones, including receiving FDA 510(k) clearance for VUNO Med-Chest X-ray Triage in November 2024 and expanding distribution channels for VUNO Med-Chest X-ray through domestic and international supply agreements in February 2024.
2024-11
Repository of AIHTA GmbH
AI-supported Chest X-Ray Analysis for Lung Cancer Detection
This report mentions the 510(k) Summary for VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage from 2024, indicating its regulatory status as an AI-supported chest X-ray analysis tool.
2024

Videos

Product demos, reviews, and walkthroughs for VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage.

View all on YouTube

Frequently Asked Questions

VUNO Med-Chest X-ray Triage is an AI-based radiological computer-assisted triage and notification software designed to quickly screen adult chest X-ray images for suspected critical findings, specifically pneumothorax and pleural effusion. Its primary function is to provide rapid automated classification results to help prioritize urgent cases, contributing to faster treatment in emergency rooms and other medical settings.
VUNO Med-Chest X-ray Triage has received U.S. FDA 510(k) Clearance, classifying it as a Class II medical device. Additionally, it holds CE Certification (Class IIa MDD) for use in European markets.
The solution is designed for flexible integration, seamlessly fitting into standard reading environments like PACS, or via AI marketplaces and distribution platforms. It can be deployed as a cloud-based service, a hybrid solution, or locally on dedicated hardware, automatically triggering analysis immediately after image acquisition to provide case-level output for worklist prioritization.
Physicians should be aware that VUNO Med-Chest X-ray Triage is specifically intended to detect pleural effusion and/or pneumothorax for prioritization purposes and not to direct attention to other anomalies. Crucially, its results are not intended for stand-alone clinical decision-making, meaning the final diagnosis and treatment plan remain the responsibility of the appropriately trained medical specialist.
Yes, there are other AI-driven chest X-ray triage solutions available, such as Lunit INSIGHT CXR Triage and BraveCX by Bering Limited, which also aim to prioritize critical conditions like pneumothorax and pleural effusion. VUNO Med-Chest X-ray Triage has demonstrated high accuracy, with AUC scores exceeding 0.95 for both pneumothorax and pleural effusion in performance evaluations.
The typical pricing model for VUNO Med-Chest X-ray Triage is subscription-based. Pricing is often determined by the number of analyses performed, with some offerings also including a pay-per-use option.
VUNO adheres to strict privacy policies, including processing pseudonymized information for research and development purposes, with segregated and restricted access to any re-identification keys. The company maintains ISO/IEC 27001:2022 and ISO/IEC 27701:2019 certifications, demonstrating its commitment to industry-standard data protection controls and secure data processing practices.

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