Rayvolve PTX-PE is an AI-based software tool designed to automatically analyze chest X-ray images for critical findings like pleural effusion and pneumothorax. It helps healthcare professionals prioritize cases by providing study-level notifications for worklist management, thereby improving the efficiency of radiological workflows without replacing clinical decision-making.
Intended Use
Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior or Antero-Posterior) of patients 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax).
Technology
Rayvolve PTX-PE uses AI-based analysis algorithms to analyze DICOM format chest X-rays for features suggestive of pneumothorax and pleural effusion. It operates on a cloud platform connected to medical center DICOM node servers, provides study-level notifications for worklist prioritization, and integrates with existing PACS and clinical-grade image viewers.
Performance
The device was validated with a large test dataset of 2000 chest X-rays (1000 pneumothorax and 1000 pleural effusion cases) showing high sensitivity, specificity, and AUC for both conditions. It demonstrated equivalent or better performance compared to the predicate device, Lunit INSIGHT CXR Triage, and met FDA software verification, validation, and usability standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/11/2024
3 months - 2
FDA Approval
3/21/2025
Other devices from AZmed
- Rayvolve LN2025 • 510K
- Rayvolve2024 • 510K
- Rayvolve2022 • 510K
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