AIMI-Triage CXR PTX
Regulatory Status Disclosed
Overview
RADLogics’ AIMI-Triage CXR PTX Application is a notification-only triage workflow tool designed for use by hospital networks and clinics. It identifies and helps prioritize chest X-rays acquired in acute settings for urgent review by hospital radiologists. The device operates in parallel to and independently of standard image interpretation workflows. Utilizing an artificial intelligence algorithm, it analyzes images for features suggestive of moderate to large sized pneumothorax, making case-level output available to a PACS/workstation for worklist prioritization or triage. This FDA-cleared solution aims to enhance efficiency and reduce radiologist burnout by flagging scans with suspected pneumothorax for immediate attention, thereby supporting improved patient outcomes. RADLogics specializes in AI and machine learning image analysis, integrating seamlessly into existing radiology workflows to reduce diagnostic turnaround time from hours to minutes through automated detection and report generation functions.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered image analysis for chest X-rays
- Automated detection of pneumothorax
- Triage workflow tool for urgent cases
- Prioritization of chest X-rays for radiologist review
- Seamless integration with existing PACS/workstations
- Operates in parallel to standard workflow
- Analyzes for moderate to large sized pneumothorax
- Cloud-based (Microsoft Azure, AWS) or on-premise deployment
- No additional training or workflow changes required for radiologists
Use Cases
- Prioritizing urgent chest X-ray reviews for pneumothorax
- Reducing diagnostic turnaround time for critical findings
- Improving radiologist efficiency and productivity
- Augmenting acute care teams with rapid clinical insights
- Supporting better patient outcomes through timely diagnosis
- Alleviating radiologist burden in high-volume settings
What Physicians Need to Know
DICOM Support & Standards
The AIMI-Triage CXR PTX application is designed to be compatible with existing PACS viewers and worklists, making case-level output available for prioritization. Integration involves identifying and mapping DICOM tags for actionable information within the hospital's PACS environment.
PACS Integration Method
The tool integrates by making case-level output available to a PACS/workstation for worklist prioritization or triage. It operates in parallel to and independent of the standard image interpretation workflow, sending notifications directly to the PACS worklist, often via a secondary capture DICOM image.
Reading Room Workflow Impact
As a notification-only triage tool, it identifies and helps prioritize chest X-rays suggestive of moderate to large pneumothorax for urgent review by radiologists. This can significantly reduce turnaround times, particularly during on-call hours, by flagging critical cases for immediate attention while others proceed for routine review.
AI Model Architecture (deep learning approach)
The device utilizes an artificial intelligence algorithm, trained via pattern recognition, to analyze chest X-ray images for features suggestive of moderate to large pneumothorax. It employs deep learning algorithms for computer vision.
Processing Speed (per study)
The average time for the AIMI-Triage CXR PTX to analyze a study and send a notification to the PACS worklist is 20.3 seconds.
FDA Clearance Pathway (510k/De Novo)
The AIMI-Triage CXR PTX received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under K193300.
Supported Modalities (CT/MRI/X-ray/US)
This tool is specifically designed for Chest X-rays (CXR).
Sensitivity & Specificity Data
The device demonstrated a sensitivity of 92% (95% CI: [86%, 96%]) and a specificity of 90% (95% CI: [84%, 95%]) for detecting moderate to large sized pneumothorax. The Area Under the Curve (AUC) was 96.7% (95% CI: [95.0%, 98.4%]).
RSNA/ACR Validation
The application was validated and trained through a multi-center study for detecting pneumothorax in hundreds of chest X-rays. Its real-world performance and utility in triaging scans have been assessed in studies, with findings often presented at forums like RSNA, highlighting its ability to improve reporting times.
Physician Tip
AIMI-Triage CXR PTX is a notification-only triage tool for prioritizing chest X-rays with suspected moderate to large pneumothorax. It operates in parallel with existing workflows and does not replace the radiologist's diagnostic interpretation. Radiologists remain responsible for full patient evaluation and making care-related decisions. The tool is not intended for diagnostic use beyond notification.
The solution is designed for seamless integration with existing PACS and worklist systems, leveraging DICOM standards for output. It can be deployed both on-premise and via the cloud, facilitating rapid deployment across multiple hospitals without requiring extensive new IT infrastructure.
Details
| Category | Radiology & Imaging AI, Triage & ER/ICU AI |
| Pricing | Unknown |
| Deployment | On-premise; Cloud (Microsoft Azure, AWS) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The AIMI-Triage CXR PTX Application received 510(k) clearance (K193300) on April 8, 2020, as a notification-only triage workflow tool to identify and prioritize chest X-rays for suspected moderate to large sized pneumothorax. |
| Integrations | |
| EHR | Not specified |
| Specialties | Emergency Medicine, Pulmonology, Radiology |
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Press & Coverage
RADLogics, Inc.
AIMI-Triage CXR PTX | RADLogics, Inc. radiology AI profile
AIMI-Triage CXR PTX is an FDA-cleared radiology AI listing for X-ray/Radiography, providing a notification-only triage workflow tool. It is designed to identify and prioritize chest X-rays suggestive of moderate to large pneumothorax for review by radiologists.
unknown
LSMU CRIS
The role of Artificial Intelligence (AI) in radiology: The current status of FDA approved systems - LSMU CRIS
This article reviews the current status of FDA-approved AI/ML-based systems in radiology, highlighting that AIMI-Triage CXR PTX by RADLogics Inc. received 510(k) premarket notification approval in 2020. It functions as a notification-only triage workflow system to identify and prioritize chest X-rays for moderate to significant pneumothorax cases.
2021-03
FDA
510(k) Premarket Notification - FDA
This FDA document details the 510(k) Premarket Notification for AIMI-Triage CXR PTX, submitted by Radlogics, Inc. It lists the applicant and correspondent information, regulation number, and classification product code, confirming its regulatory clearance.
2026-06
RADLogics
RADLogics - Physician Ai Tools
RADLogics highlights its AIMI-Triage CXR PTX as an FDA-cleared AI-powered triage tool. The company's resources include news, demos, and interviews about their radiology and imaging AI solutions.
2026-04
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing - Innolitics
This guide on AI/ML SaMD Ground Truthing references RADLogics, Inc.'s AIMI-Triage CXR PTX, noting that its output was compared to ground truth established by three independent US-board certified radiologists. The ground truthing process involved blinding the truthers to other results and existing reports.
2025-09
PMC
Computational healthcare: Present and future perspectives (Review) - PMC
This review article on computational healthcare lists AIMI-Triage CXR PTX by RadLogics, Inc. as an FDA-approved AI-based application for diagnosis in radiology in 2020. It highlights the increasing number of AI-based applications approved by the FDA, particularly in image recognition for diagnostics.
2021-12
PMC
Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan - PMC
This systematic analysis includes AIMI-Triage CXR PTX by RADLogics Inc. as an AI/ML-based medical device approved for triage and notification of pneumothorax. It details the device's classification as a Computer-Assisted Triage (CAST) system and its performance metrics.
2022-10
medRxiv
Evaluation of an artificial intelligence model for detection of pneumothorax and tension pneumothorax on chest radiograph | medRxiv
This study evaluates an AI model for pneumothorax detection on chest radiographs, noting that several AI models, including AIMI-Triage CXR PTX, have received FDA clearance for pneumothorax identification. These models are designed as computer-assisted triage devices to prioritize time-sensitive findings.
2022-07
Videos
Product demos, reviews, and walkthroughs for AIMI-Triage CXR PTX.
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Frequently Asked Questions
AIMI-Triage CXR PTX is designed as a notification-only triage workflow tool that operates in parallel to your standard image interpretation workflow. It uses an AI algorithm to analyze chest X-rays for features suggestive of moderate to large pneumothorax and makes this case-level output available to your PACS/workstation for worklist prioritization or triage.
AIMI-Triage CXR PTX has received FDA 510(k) clearance as a Class II medical device for radiological computer-aided triage and notification software. As a medical device, it is subject to regulations concerning patient data privacy, typically adhering to standards like HIPAA, though specific data handling protocols would be detailed in its implementation guide.
Alternatives include traditional manual radiologist review, which can be prone to delays, especially during high-volume periods. Other AI-based solutions for pneumothorax detection and triage, such as Zebra Medical Vision's HealthPNX (its predicate device), GE HealthCare's Critical Care Suite, and other FDA-cleared AI models like Lunit INSIGHT CXR Triage and Annalise Enterprise CXR Triage Pneumothorax, also exist.
While specific pricing for AIMI-Triage CXR PTX isn't publicly detailed, similar healthcare AI solutions often utilize subscription models, per-study fees, or enterprise licenses. Factors influencing cost typically include the volume of studies, integration complexity with existing PACS/EHR systems, and the scope of deployment across a hospital network.
AIMI-Triage CXR PTX is a notification-only tool and does not replace the radiologist's review and diagnosis; it is not for diagnostic use beyond notification. Clinical studies have shown similar AI models for pneumothorax detection to have sensitivities ranging from 84.3% to 94.65% and specificities between 87.95% and 95.1%, with some limitations for smaller pneumothoraces or in specific imaging conditions. The device is limited to analyzing imaging data as a guide to possible urgency and should not be used in lieu of full patient evaluation.
The AIMI-Triage CXR PTX was evaluated in a blinded, retrospective, and multi-center study for detecting pneumothorax in chest X-rays. It demonstrated an area under the curve (AUC) of 96.7%, with a sensitivity of 92% and specificity of 90% for detecting moderate to large sized pneumothorax.
The system is designed to prioritize urgent cases by flagging chest X-rays suggestive of pneumothorax, potentially reducing reporting delays and improving turnaround times for critical findings. This allows radiologists to focus on high-priority studies more quickly, thereby augmenting their ability to manage heavy workloads.
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| Last Verified: 2026-04-20 | First Added: 2026-04-20