Rayvolve PTX-PE

JSON twin: https://www.healthaidb.com/software/rayvolve-ptx-pe.json

Company Name

AZmed

Product URL

https://www.azmed.com/products/rayvolve-ptx-pe

Company URL

https://www.azmed.com

Categories

• diagnostic Support
• clinical Care
• radiology
• imaging Software
• Diagnostic
• Clinical
• Ai-powered Imaging

Summary

Rayvolve PTX-PE is an AI-powered software by AZmed that analyzes chest X-rays to detect pneumothorax and pleural effusion, aiding radiologists in prioritizing critical cases.

Description

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. 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. Rayvolve PTX-PE is a standalone AI deep learning software that processes DICOM format chest X-rays. It integrates with clinical DICOM nodes like PACS, runs on-premise or cloud, and outputs fracture detection predictions as annotated images to assist doctors. It uses supervised deep learning models retrained on large datasets of osteoarticular X-rays including pediatric cases.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark (MDR)

Company Founding

2018

Company Offices

• France
• United States
• Germany
• United Kingdom
• Italy
• Spain
• Netherlands
• Belgium
• Switzerland
• Canada

Compliance

• HIPAA
• GDPR
• FDA 510(k)
• CE Mark (MDR)

Customers

Data Residency

US/EU regions

Data Standards

• DICOM

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-based analysis of chest X-rays for pneumothorax and pleural effusion detection
• Study-level notifications for worklist prioritization
• Integration with existing PACS and clinical-grade image viewers
• Cloud-based operation connected to medical center DICOM node servers
• High sensitivity and specificity for both pneumothorax and pleural effusion detection

Id

SW0063

Integration Partners

Integrations

• PACS
• clinical-grade image viewers

Languages Supported

• English
• French
• Spanish
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Javanese
• Turkish
• Vietnamese
• Telugu
• Marathi

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• consent mgmt
• anonymization
• data minimization

Product Code

SW0063

Product Name

Rayvolve PTX-PE

Ratings

Regions Available

• United States
• Europe
• Asia
• Africa
• Australia
• South America
• North America
• Middle East
• Oceania
• Caribbean
• Central America
• Southeast Asia
• East Asia
• South Asia
• Sub-Saharan Africa
• North Africa
• Central Asia
• Western Europe
• Eastern Europe
• Northern Europe
• Southern Europe

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• audit logs
• 2FA
• DLP

Specialties

• Radiology
• Emergency Medicine
• Pulmonology

Support Channels

System Requirements

Major OS/DB/hardware needs, or empty if SaaS-only

Target Users

• radiologists
• emergency physicians
• healthcare professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Rayvolve PTX-PE",
  "company_name": "AZmed",
  "product_url": "https://www.azmed.com/products/rayvolve-ptx-pe",
  "company_url": "https://www.azmed.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0063",
  "summary": "Rayvolve PTX-PE is an AI-powered software by AZmed that analyzes chest X-rays to detect pneumothorax and pleural effusion, aiding radiologists in prioritizing critical cases.",
  "description": "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. 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. Rayvolve PTX-PE is a standalone AI deep learning software that processes DICOM format chest X-rays. It integrates with clinical DICOM nodes like PACS, runs on-premise or cloud, and outputs fracture detection predictions as annotated images to assist doctors. It uses supervised deep learning models retrained on large datasets of osteoarticular X-rays including pediatric cases.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "radiology",
    "imaging Software",
    "Diagnostic",
    "Clinical",
    "Radiology",
    "Ai-powered Imaging"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "radiologists",
    "emergency physicians",
    "healthcare professionals"
  ],
  "specialties": [
    "Radiology",
    "Emergency Medicine",
    "Pulmonology"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Asia",
    "Africa",
    "Australia",
    "South America",
    "North America",
    "Middle East",
    "Oceania",
    "Caribbean",
    "Central America",
    "Southeast Asia",
    "East Asia",
    "South Asia",
    "Sub-Saharan Africa",
    "North Africa",
    "Central Asia",
    "Western Europe",
    "Eastern Europe",
    "Northern Europe",
    "Southern Europe"
  ],
  "languages_supported": [
    "English",
    "French",
    "Spanish",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Javanese",
    "Turkish",
    "Vietnamese",
    "Telugu",
    "Marathi"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "France",
    "United States",
    "Germany",
    "United Kingdom",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Switzerland",
    "Canada"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "AI-based analysis of chest X-rays for pneumothorax and pleural effusion detection",
    "Study-level notifications for worklist prioritization",
    "Integration with existing PACS and clinical-grade image viewers",
    "Cloud-based operation connected to medical center DICOM node servers",
    "High sensitivity and specificity for both pneumothorax and pleural effusion detection"
  ],
  "optional_modules": [],
  "integrations": [
    "PACS",
    "clinical-grade image viewers"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "Major OS/DB/hardware needs, or empty if SaaS-only",
  "compliance": [
    "HIPAA",
    "GDPR",
    "FDA 510(k)",
    "CE Mark (MDR)"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark (MDR)"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "consent mgmt",
    "anonymization",
    "data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0063",
  "slug": "rayvolve-ptx-pe",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/rayvolve-ptx-pe.json"
  }
}