Rayvolve PTX-PE

by AZmed  · Based in France → — Your AI Partner for Medical Imaging
Emergency Medicine Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

Rayvolve PTX-PE, developed by AZmed, is an FDA-cleared and CE-marked artificial intelligence solution designed to optimize radiologists’ and emergency physicians’ workflows by augmenting their diagnostic capabilities for chest X-rays. This radiological computer-assisted triage and notification software specifically analyzes chest X-ray images (Postero-Anterior or Antero-Posterior) of patients 18 years of age or older for the presence of suspected critical findings such as pleural effusion and/or pneumothorax.

The tool leverages advanced AI algorithms to provide study-level output for worklist prioritization or triage, seamlessly integrating into existing PACS/RIS environments via DICOM node servers. Rayvolve PTX-PE acts as a passive notification system, not intended to direct attention to specific image portions or to be used as a stand-alone basis for clinical decision-making, but rather as a valuable second opinion to enhance diagnostic accuracy and reduce report turnaround times. AZmed’s Rayvolve AI Suite, which includes PTX-PE, is utilized in over 2,500 healthcare facilities worldwide, demonstrating its proven impact on improving diagnostic consistency and operational efficiency in medical imaging.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Radiological computer-assisted triage and notification software
  • Analyzes chest X-ray images for pleural effusion and/or pneumothorax
  • Utilizes artificial intelligence algorithms
  • Provides study-level output for worklist prioritization or triage
  • Seamless integration with DICOM node servers (PACS/RIS)
  • Passive notification system for workflow enhancement
  • Not intended for stand-alone clinical decision-making
  • Compatible with adult chest X-rays (patients 18 years or older)
  • Processing time of less than one minute (for Rayvolve suite)
  • Input and output in DICOM format

Use Cases

  • Triage and prioritization of chest X-rays in emergency departments
  • Detection of suspected critical findings like pleural effusion and pneumothorax
  • Optimizing physicians' workflows in radiology
  • Augmenting diagnostic accuracy and consistency for chest X-rays
  • Reducing report turnaround time for critical cases
  • Providing an AI-based second opinion for radiologists

What Physicians Need to Know

DICOM Support & Standards
Rayvolve PTX-PE utilizes the current edition of the DICOM image standard, enabling interaction with existing DICOM node servers (e.g., PACS) and clinical-grade image viewers. Input and output are in DICOM format.
PACS Integration Method
The solution offers seamless integration into existing PACS and RIS, providing study-level outputs to the DICOM node server for worklist prioritization or triage without requiring additional clicks from physicians. It can be deployed on a cloud platform or connected to the radiology center's local network.
Reading Room Workflow Impact
Rayvolve PTX-PE functions as a radiological computer-assisted triage and notification software, improving workflow by prioritizing urgent cases, reducing turnaround time (e.g., up to 77% reduction in TAT for urgent cases and 35.81% reduction in reading time with AI assistance), and lowering interpretation effort. It flags critical findings for radiologists, optimizing resource use.
AI Model Architecture (deep learning approach)
The Rayvolve algorithm is a deep learning (DL)-based AI tool, specifically an ensembling algorithm composed of five object-detection models based on the RetinaNet architecture with a VGG-16 backbone.
Processing Speed (per study)
The processing time for Rayvolve is reported to be less than one minute per study.
FDA Clearance Pathway (510k/De Novo)
Rayvolve PTX-PE has received FDA 510(k) clearance. The broader Rayvolve solution also has expanded 510(k) clearance for pediatric fracture detection.
Supported Modalities
Rayvolve PTX-PE specifically analyzes chest X-ray images (Postero-Anterior (PA) or Antero-Posterior (AP) views) for the presence of suspected critical findings such as pleural effusion and/or pneumothorax.
Sensitivity & Specificity Data
For standalone performance, Rayvolve PTX-PE demonstrates an AUC of 0.9686 for pleural effusion (95% CI: [0.9547, 0.9824]) with 89.86% sensitivity (95% CI: [86.72, 93.00]), and an AUC of 0.9830 for pneumothorax (95% CI: [0.9778, 0.9880]) with 91.34% sensitivity (95% CI: [0.8874, 0.9339]). Overall standalone performance for thoracic anomalies shows an AUC of 0.9358, sensitivity of 0.964, and specificity of 0.8435.
RSNA/ACR Validation
AZmed's Rayvolve products were showcased at RSNA 2023, where studies were presented on AI-supported X-ray worklist prioritization and fracture detection, including a large retrospective analysis by SimonMed Imaging.
Physician Tip

Rayvolve PTX-PE serves as a valuable computer-assisted triage and notification tool for chest X-rays, prioritizing critical findings like pneumothorax and pleural effusion. It is designed to integrate seamlessly into existing workflows, reducing interpretation time and improving diagnostic accuracy, particularly in high-volume settings. Physicians should note that it provides adjunctive information for worklist prioritization and is not intended to replace medical doctors or be used as a standalone diagnostic tool. The AI's ability to flag urgent cases can help reduce radiologist fatigue and ensure timely review of critical conditions. It supports both adult and pediatric populations (u226518 years for PTX/PE, u22652 years for general Rayvolve fracture detection).

Rayvolve PTX-PE is designed for seamless integration with existing PACS and RIS systems via DICOM standards, ensuring minimal disruption to current radiology workflows. It can operate on a cloud platform or within the local network of a radiology center, interacting directly with DICOM node servers to provide study-level outputs for worklist prioritization. This 'no-click' integration aims to enhance efficiency without requiring radiologists to adopt new interfaces or additional steps.

Details

Category Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Contact for pricing
DeploymentCloud-based platform, connected to radiology center's local network, interacts with DICOM Node servers for PACS/RIS integration.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Rayvolve PTX-PE (K243808) received FDA Class II clearance on March 21, 2025. It is a radiological computer-assisted triage and notification software for analyzing chest X-ray images of patients 18 years or older for suspected pleural effusion and/or pneumothorax.

Integrations
EHR Not specified
Specialties Emergency Medicine, Radiology

What the Web Says

Rayvolve PTX-PE is an AI-powered software designed to assist healthcare professionals in triaging adult chest X-ray images for suspected critical findings like pleural effusion and pneumothorax. It aims to improve diagnostic accuracy, reduce turnaround times, and optimize workflow in emergency departments and radiology practices. The software integrates seamlessly with existing PACS/RIS systems, providing passive notifications for prioritization.

Overall: Positive

Strengths

  • Improved sensitivity and accuracy in detecting pneumothorax and pleural effusion.
  • Reduced reading and interpretation time for radiologists and emergency physicians.
  • Assists less experienced doctors and residents, acting as a safety net against oversights.
  • Seamless integration with existing PACS/RIS workflows without adding extra clicks.
  • FDA-cleared and CE-marked, indicating regulatory compliance and validation.
  • Can prioritize critical cases, leading to faster diagnosis and treatment.

Limitations

  • Specificity can be lower compared to human radiologists in standalone performance.
  • Lack of pricing transparency, requiring direct engagement for cost assessment.
  • Some AI tools, in general, have been reported to produce false positives, leading to additional review time.
  • Not intended for standalone clinical decision-making.
  • Narrower in scope compared to comprehensive PACS/RIS solutions.

Based on reviews from: AZmed (azmed.co), Vertex AI Search, FDA (accessdata.fda.gov), PMC (ncbi.nlm.nih.gov), Reddit (r/Radiology, r/Residency), Physician AI Tools

Last updated: 2026-07-18

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Press & Coverage

FDA
K243808 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification details the clearance of Rayvolve PTX-PE by AZmed, classifying it as a Class II medical device. It specifies the applicant, contact information, regulation number, product code, and the date of receipt of the application (December 11, 2024).
2026-06
FDA
March 21, 2025 AZmed Anthony Joseph QARA Associate 10 Rue d'Uzu00e8s Paris, 75002 France Re: K243808 Trade/Device Name: Rayvolve P - accessdata.fda.gov
This FDA document from March 21, 2025, provides details on the Rayvolve PTX-PE device, clarifying its intended use as a radiological computer-assisted triage and notification software for chest x-ray images of patients 18 years or older to detect suspected critical findings like pleural effusion and/or pneumothorax. It emphasizes that the device does not replace medical doctors and its results are not for stand-alone clinical decision-making.
2025-03
AZmed
Rayvolve AI Suite now Available in Fujifilm Synapse PACS - AZmed
Fujifilm has partnered with AZmed to integrate the complete Rayvolve AI Suite, including Rayvolve PTX-PE, into Fujifilm's Synapse PACS, with AZ Sint-Blasius in Belgium being the first hospital to implement these integrated AI solutions. This integration aims to improve radiological workflow, productivity, and patient care by seamlessly delivering AI results without additional clicks.
2026-03
AZmed
AI in radiology can help reduce burnout - AZmed
This article highlights how AZmed's Rayvolve AI Suite, including Rayvolve PTX-PE, helps combat radiologist burnout by automating tasks, triaging urgent cases, and strengthening diagnostic confidence in over 2,500 healthcare facilities globally. Rayvolve PTX/PE is described as a radiological computer-assisted triage and notification software for detecting suspected critical findings like pleural effusion and/or pneumothorax on chest x-rays.
2025-08
AZmed
AZmed and RADIN Health partner to bring AI radiology tools to U.S. hospitals, imaging centers, and radiology practices
AZmed has partnered with RADIN Health to make its Rayvolve products, including AZchest for thoracic abnormalities, available across RADIN's network in the U.S., addressing the projected shortage of radiologists. Rayvolve PTX-PE is specifically mentioned as a radiological computer-assisted triage and notification software for chest x-ray analysis.
2026-04
AZmed
Using AI for Chest Detection in Radiology - AZmed
This article explains how AI chest detection, specifically AZchest within the Rayvolve AI Suite, works to improve medical imaging capabilities and clinical advantages. Rayvolve PTX/PE is identified as a radiological computer-assisted triage and notification software that analyzes chest x-ray images for critical findings such as pleural effusion and/or pneumothorax.
2025-08
AZmed
AI worklist triage for X-rays throughput and case mix - AZmed
AZmed's Rayvolve AI Suite, including Rayvolve PTX-PE, offers clinically validated AI solutions for X-ray triage, aiming to improve throughput, reduce turnaround time, and optimize resource use in radiology workflows. Rayvolve PTX/PE analyzes chest x-ray images for suspected pneumothorax and pleural effusion, surfacing urgent thoracic studies.
2026-04
Innolitics
Command Line as a Medical Device (CLaMD) - Innolitics
This article discusses Command Line as a Medical Device (CLaMD) and mentions Rayvolve PTX-PE as an example of software that provides study-level output in DICOM node servers for worklist prioritization or triage. It highlights that Rayvolve PTX-PE operates in the background and integrates with existing systems without its own interactive GUI.
2025-05

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Frequently Asked Questions

Rayvolve PTX-PE is designed to seamlessly integrate with existing Picture Archiving and Communication Systems (PACS) and DICOM node servers, requiring no additional steps for radiologists to incorporate it into their workflows. It functions as a radiological computer-assisted triage and notification software, analyzing chest X-ray images of adult patients (18 years or older) for suspected critical findings such as pleural effusion and/or pneumothorax to prioritize cases.
Yes, Rayvolve PTX-PE is FDA-cleared as a Class II medical device in the United States and holds CE-mark Class IIa in Europe, demonstrating compliance with relevant medical device regulations. While the search results confirm regulatory clearances, specific details on HIPAA compliance are generally covered by the vendor's privacy policy and secure integration practices, which would need to be confirmed directly with AZmed.
Rayvolve PTX-PE is a passive notification tool for prioritization and is not intended for standalone clinical decision-making or to direct attention to specific image portions. Physicians should interpret its findings as supplementary information to assist with triage and workflow prioritization, not as a replacement for their professional diagnostic interpretation.
Rayvolve PTX-PE focuses on triage and notification for pneumothorax and pleural effusion in adults, aiming to improve throughput and reduce turnaround times. While the search results mention other AI tools for fracture detection and general chest abnormalities, a direct head-to-head comparison with specific competing AI solutions for PE/PTX triage was not detailed.
The pricing for Rayvolve PTX-PE is contract-based, determined by the duration and terms agreed upon with the vendor, AZmed. Depending on the deployment, additional AWS infrastructure costs may apply if the solution is hosted on the AWS cloud platform.
Rayvolve PTX-PE is part of the AZmed Rayvolve AI Suite, which has been rigorously validated through clinical research and deployed in over 2,500 healthcare facilities worldwide. Studies indicate that AI-assisted CXR triage can accurately triage findings, achieving significant reductions in turnaround time and high specificity in urgent cases.
Rayvolve PTX-PE is explicitly designed as a computer-assisted triage and notification software to assist radiologists and emergency physicians, not to replace their diagnostic role. It acts as a supplementary tool to highlight regions of concern and prioritize cases, thereby reducing cognitive effort and optimizing resource use.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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