ClearRead Xray Pneumothorax

JSON twin: https://www.healthaidb.com/software/clearread-xray-pneumothorax.json

Company Name

Riverain Technologies

Product URL

https://www.riveraintech.com/clearread-xray-pneumothorax

Company URL

https://www.riveraintech.com

Categories

• diagnostic Support
• clinical Care
• radiology
• imaging Software
• clinical Decision Support
• clinical Workflow Optimization
• ai Clinical Documentation Integrity
• regulatory Compliance
• Diagnostic
• Clinical
• Ai-powered Imaging
• Triage System
• Workflow Optimization
• Pneumothorax Detection
• Image Processing
• Machine Learning
• Fda-cleared Software

Summary

ClearRead Xray Pneumothorax is an AI-powered software tool that analyzes adult chest X-rays to identify signs of pneumothorax larger than 5 mm, aiding radiologists in prioritizing urgent cases without replacing diagnostic interpretation.

Description

ClearRead Xray Pneumothorax is an FDA-cleared AI software designed to analyze adult chest X-rays for signs of pneumothorax exceeding 5 mm. It functions as a triage system, notifying radiologists about suspected urgent cases to prioritize workflow, without substituting diagnostic interpretation. The software utilizes machine learning and image processing algorithms to assess digital frontal chest radiographs received via DICOM protocol, providing case-level outputs for worklist prioritization. It requires both lungs to be visible and normalizes image characteristics to mitigate device differences, effectively detecting patterns clinically significant for pneumothorax identification. Clinical performance testing on an independent dataset of over 1,100 adult chest X-rays demonstrated high accuracy, with an AUC-ROC of 0.974, sensitivity of 0.922, specificity of 0.951, and an average notification time of 9.73 seconds, supporting its effectiveness as a triage tool. The device underwent extensive non-clinical testing per FDA Quality System regulations and ISO standards, including software lifecycle and risk management compliance. ClearRead Xray Pneumothorax is compatible with all upright and portable devices and integrates seamlessly with PACS, eliminating the need for a separate application viewer or additional logins. It performs robustly in the presence of common co-morbidities, including pleural effusion, atelectasis, lung opacities, pneumonia, and edema. The software is FDA-cleared and holds a CE Mark, ensuring its safety and effectiveness in clinical settings.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark (MDR Class IIa)
• TGA approval
• ISO 27001

Company Founding

2008

Company Offices

• United States
• Canada
• United Kingdom
• Germany
• France
• Italy
• Spain
• Australia
• New Zealand
• Saudi Arabia

Compliance

• FDA 510(k)
• CE Mark (MDR Class IIa)
• TGA approval
• HIPAA

Customers

Data Residency

US and international deployment options (on-prem or cloud region selection depending on customer); regional hosting available per contract

Data Standards

• DICOM
• HL7 v2
• IHE profiles

Deployment Model

• on_prem
• cloud
• hybrid

Features

• Triage notification for potential pneumothorax cases 5mm or larger
• Seamless PACS integration without separate viewer or logins
• High sensitivity and specificity across multiple devices and co-morbidities
• FDA-cleared and CE-marked

Id

SW0430

Integration Partners

Integrations

• PACS
• GE Healthcare
• Sectra
• Siemens Healthineers
• Volpara Health
• Aidoc
• Blackford Analysis
• CARPL.AI
• Nuance PowerScribe 360
• Philips
• Toyo International
• Nuance
• Fujifilm
• TeraRecon
• Change HC PACS
• AGFA HealthCare
• Calantic
• CARPL.ai Marketplace

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Dutch
• Portuguese
• Arabic
• Chinese
• Japanese
• Korean
• Russian
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Windows
• Linux
• PACS review station

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• consent management
• anonymization
• data minimization

Product Code

SW0430

Product Name

ClearRead Xray Pneumothorax

Ratings

Regions Available

• United States
• Canada
• United Kingdom
• Germany
• France
• Italy
• Spain
• Australia
• New Zealand
• Saudi Arabia
• South Africa
• Belgium
• Netherlands
• Sweden
• Norway
• Denmark
• Finland
• Switzerland
• Austria
• Japan

Related Urls

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

Release Year

""

Security Features

• data encryption in transit and at rest
• role-based access control (RBAC)
• audit logging
• single sign-on (SSO) / SAML support

Specialties

• Radiology
• Pulmonology
• Emergency Medicine
• Thoracic Surgery
• Critical Care
• Internal Medicine
• Cardiology
• Oncology
• Pneumology
• Intensive Care
• Pulmonary Medicine
• Emergency Radiology
• Trauma Care
• Respiratory Medicine
• Cardiothoracic Surgery
• Vascular Surgery
• Interventional Radiology
• Pediatric Pulmonology
• Geriatric Pulmonology
• Sports Medicine

Support Channels

System Requirements

Windows/Linux server options; typical radiology workstation/browser for viewing

Target Users

• radiologists
• clinicians
• medical imaging professionals
• healthcare providers
• hospital staff
• medical technicians
• healthcare administrators
• medical practitioners
• healthcare organizations
• medical facilities

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Riverain Technologies",
  "product_url": "https://www.riveraintech.com/clearread-xray-pneumothorax",
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  "summary": "ClearRead Xray Pneumothorax is an AI-powered software tool that analyzes adult chest X-rays to identify signs of pneumothorax larger than 5 mm, aiding radiologists in prioritizing urgent cases without replacing diagnostic interpretation.",
  "description": "ClearRead Xray Pneumothorax is an FDA-cleared AI software designed to analyze adult chest X-rays for signs of pneumothorax exceeding 5 mm. It functions as a triage system, notifying radiologists about suspected urgent cases to prioritize workflow, without substituting diagnostic interpretation. The software utilizes machine learning and image processing algorithms to assess digital frontal chest radiographs received via DICOM protocol, providing case-level outputs for worklist prioritization. It requires both lungs to be visible and normalizes image characteristics to mitigate device differences, effectively detecting patterns clinically significant for pneumothorax identification. Clinical performance testing on an independent dataset of over 1,100 adult chest X-rays demonstrated high accuracy, with an AUC-ROC of 0.974, sensitivity of 0.922, specificity of 0.951, and an average notification time of 9.73 seconds, supporting its effectiveness as a triage tool. The device underwent extensive non-clinical testing per FDA Quality System regulations and ISO standards, including software lifecycle and risk management compliance. ClearRead Xray Pneumothorax is compatible with all upright and portable devices and integrates seamlessly with PACS, eliminating the need for a separate application viewer or additional logins. It performs robustly in the presence of common co-morbidities, including pleural effusion, atelectasis, lung opacities, pneumonia, and edema. The software is FDA-cleared and holds a CE Mark, ensuring its safety and effectiveness in clinical settings.",
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  "languages_supported": [
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    "Saudi Arabia"
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  "company_founding": "2008",
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  "features": [
    "Triage notification for potential pneumothorax cases 5mm or larger",
    "Seamless PACS integration without separate viewer or logins",
    "High sensitivity and specificity across multiple devices and co-morbidities",
    "FDA-cleared and CE-marked"
  ],
  "optional_modules": [],
  "integrations": [
    "PACS",
    "GE Healthcare",
    "Sectra",
    "Siemens Healthineers",
    "Volpara Health",
    "Aidoc",
    "Blackford Analysis",
    "CARPL.AI",
    "Nuance PowerScribe 360",
    "Philips",
    "Toyo International",
    "Nuance",
    "Fujifilm",
    "TeraRecon",
    "Change HC PACS",
    "AGFA HealthCare",
    "Calantic",
    "CARPL.ai Marketplace"
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  "data_standards": [
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    "TGA approval",
    "HIPAA"
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    "ISO 27001"
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    "role-based access control (RBAC)",
    "audit logging",
    "single sign-on (SSO) / SAML support"
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    "consent management",
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  "training_options": [],
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  "id": "SW0430",
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  "last_updated": "2025-10-11",
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