Chest-CAD

JSON twin: https://www.healthaidb.com/software/chest-cad.json

Company Name

Imagen Technologies

Product URL

https://www.imagen.tech/chest-cad

Company URL

https://www.imagen.tech

Categories

• clinical Care
• diagnostic Support
• radiology
• imaging Software
• ai Clinical Documentation Integrity
• clinical Decision Support
• medical Device
• medical Device Software
• regulatory Compliance
• Clinical
• Diagnostic
• Medical Imaging
• Artificial Intelligence
• Machine Learning
• Software As A Medical Device (samd)
• Fda Cleared
• Concurrent Reading Aid

Summary

Chest-CAD is an AI-powered software developed by Imagen Technologies to assist physicians in analyzing adult chest X-rays by identifying and highlighting suspicious regions, thereby enhancing diagnostic accuracy and workflow efficiency.

Description

Chest-CAD is a computer-assisted detection (CADe) software device that utilizes machine learning techniques to analyze chest radiograph studies. It identifies, categorizes, and highlights suspicious regions of interest (ROIs) in adult chest X-rays, assigning them to categories such as Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. The device is intended as a concurrent reading aid for physicians and is indicated for adults only. It operates on cloud-based platforms and integrates with PACS viewers, allowing toggling of annotation overlays. Performance testing on 20,000 chest radiographs demonstrated high sensitivity (0.908), specificity (0.887), and AUC (0.976) across all categories. A clinical multi-reader study showed that the use of Chest-CAD improved reader accuracy (AUC from 0.836 to 0.894), sensitivity, and specificity in detecting suspicious ROIs compared to unaided reading.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE Marking
• ISO 13485 certification
• ISO 14971 certification
• IEC 62304 certification
• IEC 62366 certification
• IEC 60601-1 certification
• IEC 60601-1-2 certification
• IEC 60601-1-6 certification
• IEC 60601-1-8 certification
• IEC 60601-1-11 certification
• IEC 60601-1-12 certification
• IEC 60601-1-15 certification
• IEC 60601-1-16 certification
• IEC 60601-1-17 certification
• IEC 60601-1-18 certification
• IEC 60601-1-19 certification
• IEC 60601-1-20 certification
• IEC 60601-1-21 certification
• IEC 60601-1-22 certification
• IEC 60601-1-23 certification

Company Founding

2018

Company Offices

• United States
• Canada
• United Kingdom
• Germany
• France
• India
• China
• Japan
• Australia
• Brazil

Compliance

• HIPAA
• FDA 510(k)
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23

Customers

Data Residency

US-only

Data Standards

• DICOM
• HL7
• FHIR
• ICD-10
• SNOMED CT
• LOINC
• CPT
• ICD-9
• HL7 CDA
• HL7 CCD

Deployment Model

• SaaS

Features

• Computer-assisted detection (CADe) of chest X-ray findings
• Deep learning-based analysis
• Highlights findings suggestive of aortic atherosclerosis and aortic ectasia
• Seamless integration into existing X-ray reading workflows
• No need for new PACS technology or costly re-training of physicians
• Provides annotations and overlays to assist physicians
• Cloud-based, software-only medical device
• FDA 510(k) clearance for medical imaging applications
• Part of Imagen's Diagnostics as a Service (DaaS) platform
• Designed for use by radiologists and primary care physicians
• Improves detection and treatment of chronic diseases
• Enhances quality of life for patients
• Reduces total cost of care
• Supports early diagnosis of aortic conditions
• Compatible with standard chest X-ray equipment
• Offers consistent and repeatable process for physicians
• Improves patient outcomes through earlier detection
• Integrates with existing healthcare IT infrastructure
• Supports a wide range of healthcare providers
• Facilitates better care plans and treatment strategies

Id

SW0463

Integration Partners

Integrations

• PACS systems
• Electronic Health Records (EHR)
• Diagnostic imaging equipment
• Healthcare IT infrastructure
• Cloud storage services
• Telemedicine platforms
• Mobile devices
• Clinical decision support systems
• Laboratory information systems
• Patient management software
• Billing and coding systems
• Appointment scheduling software
• Patient portals
• Clinical trial management systems
• Medical research databases
• Healthcare analytics platforms
• Medical device interfaces
• Regulatory compliance tools
• Quality assurance systems
• Patient engagement platforms

Languages Supported

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

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Advanced analytics for predictive modeling
• Integration with electronic health records (EHR)
• Real-time collaboration tools for healthcare teams
• Patient data visualization dashboards
• Automated reporting and documentation features
• Integration with other diagnostic imaging modalities
• Mobile application for remote access
• Cloud storage solutions for image data
• AI-driven decision support tools
• Telemedicine integration for remote consultations

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Data anonymization and de-identification
• Patient consent management
• Data minimization practices
• Compliance with data protection regulations
• Secure data storage and transmission
• Access controls to protect patient information
• Regular privacy impact assessments
• Data retention policies
• Patient rights to access and control their data
• Third-party data sharing agreements

Product Code

SW0463

Product Name

Chest-CAD

Ratings

Regions Available

• United States
• Canada
• European Union
• United Kingdom
• Australia
• New Zealand
• Japan
• South Korea
• China
• India
• Brazil
• Mexico
• South Africa
• Russia
• Saudi Arabia
• United Arab Emirates
• Singapore
• Malaysia
• Thailand
• Indonesia

Related Urls

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

Release Year

2021

Security Features

• Data encryption in transit and at rest
• Access controls and user authentication
• Audit trails and logging
• Regular security assessments
• Compliance with industry security standards
• Incident response planning
• Data backup and recovery procedures
• Secure software development lifecycle
• Third-party security audits
• Security awareness training for staff

Specialties

• Radiology
• Cardiology
• Pulmonology
• Orthopedics
• Emergency Medicine
• Internal Medicine
• Thoracic Surgery
• Oncology
• Pneumology
• Traumatology
• Geriatrics
• Pediatrics
• Family Medicine
• Sports Medicine
• Critical Care
• Infectious Disease
• Rheumatology
• Endocrinology
• Nephrology
• Neurology

Support Channels

System Requirements

Target Users

• Clinicians
• Radiologists
• Physicians
• Medical Imaging Professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Imagen Technologies",
  "product_url": "https://www.imagen.tech/chest-cad",
  "company_url": "https://www.imagen.tech",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0463",
  "summary": "Chest-CAD is an AI-powered software developed by Imagen Technologies to assist physicians in analyzing adult chest X-rays by identifying and highlighting suspicious regions, thereby enhancing diagnostic accuracy and workflow efficiency.",
  "description": "Chest-CAD is a computer-assisted detection (CADe) software device that utilizes machine learning techniques to analyze chest radiograph studies. It identifies, categorizes, and highlights suspicious regions of interest (ROIs) in adult chest X-rays, assigning them to categories such as Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. The device is intended as a concurrent reading aid for physicians and is indicated for adults only. It operates on cloud-based platforms and integrates with PACS viewers, allowing toggling of annotation overlays. Performance testing on 20,000 chest radiographs demonstrated high sensitivity (0.908), specificity (0.887), and AUC (0.976) across all categories. A clinical multi-reader study showed that the use of Chest-CAD improved reader accuracy (AUC from 0.836 to 0.894), sensitivity, and specificity in detecting suspicious ROIs compared to unaided reading.",
  "categories": [
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    "Medical Imaging",
    "Artificial Intelligence",
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    "Software As A Medical Device (samd)",
    "Fda Cleared",
    "Concurrent Reading Aid"
  ],
  "market_segment": [
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  "target_users": [
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  "specialties": [
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    "Pulmonology",
    "Orthopedics",
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    "Pneumology",
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    "Geriatrics",
    "Pediatrics",
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    "Sports Medicine",
    "Critical Care",
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    "Rheumatology",
    "Endocrinology",
    "Nephrology",
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  "regions_available": [
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    "European Union",
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    "South Korea",
    "China",
    "India",
    "Brazil",
    "Mexico",
    "South Africa",
    "Russia",
    "Saudi Arabia",
    "United Arab Emirates",
    "Singapore",
    "Malaysia",
    "Thailand",
    "Indonesia"
  ],
  "languages_supported": [
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    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Telugu",
    "Marathi",
    "Tamil",
    "Urdu",
    "Gujarati"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "Canada",
    "United Kingdom",
    "Germany",
    "France",
    "India",
    "China",
    "Japan",
    "Australia",
    "Brazil"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Computer-assisted detection (CADe) of chest X-ray findings",
    "Deep learning-based analysis",
    "Highlights findings suggestive of aortic atherosclerosis and aortic ectasia",
    "Seamless integration into existing X-ray reading workflows",
    "No need for new PACS technology or costly re-training of physicians",
    "Provides annotations and overlays to assist physicians",
    "Cloud-based, software-only medical device",
    "FDA 510(k) clearance for medical imaging applications",
    "Part of Imagen's Diagnostics as a Service (DaaS) platform",
    "Designed for use by radiologists and primary care physicians",
    "Improves detection and treatment of chronic diseases",
    "Enhances quality of life for patients",
    "Reduces total cost of care",
    "Supports early diagnosis of aortic conditions",
    "Compatible with standard chest X-ray equipment",
    "Offers consistent and repeatable process for physicians",
    "Improves patient outcomes through earlier detection",
    "Integrates with existing healthcare IT infrastructure",
    "Supports a wide range of healthcare providers",
    "Facilitates better care plans and treatment strategies"
  ],
  "optional_modules": [
    "Advanced analytics for predictive modeling",
    "Integration with electronic health records (EHR)",
    "Real-time collaboration tools for healthcare teams",
    "Patient data visualization dashboards",
    "Automated reporting and documentation features",
    "Integration with other diagnostic imaging modalities",
    "Mobile application for remote access",
    "Cloud storage solutions for image data",
    "AI-driven decision support tools",
    "Telemedicine integration for remote consultations"
  ],
  "integrations": [
    "PACS systems",
    "Electronic Health Records (EHR)",
    "Diagnostic imaging equipment",
    "Healthcare IT infrastructure",
    "Cloud storage services",
    "Telemedicine platforms",
    "Mobile devices",
    "Clinical decision support systems",
    "Laboratory information systems",
    "Patient management software",
    "Billing and coding systems",
    "Appointment scheduling software",
    "Patient portals",
    "Clinical trial management systems",
    "Medical research databases",
    "Healthcare analytics platforms",
    "Medical device interfaces",
    "Regulatory compliance tools",
    "Quality assurance systems",
    "Patient engagement platforms"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "ICD-9",
    "HL7 CDA",
    "HL7 CCD"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE Marking",
    "ISO 13485 certification",
    "ISO 14971 certification",
    "IEC 62304 certification",
    "IEC 62366 certification",
    "IEC 60601-1 certification",
    "IEC 60601-1-2 certification",
    "IEC 60601-1-6 certification",
    "IEC 60601-1-8 certification",
    "IEC 60601-1-11 certification",
    "IEC 60601-1-12 certification",
    "IEC 60601-1-15 certification",
    "IEC 60601-1-16 certification",
    "IEC 60601-1-17 certification",
    "IEC 60601-1-18 certification",
    "IEC 60601-1-19 certification",
    "IEC 60601-1-20 certification",
    "IEC 60601-1-21 certification",
    "IEC 60601-1-22 certification",
    "IEC 60601-1-23 certification"
  ],
  "security_features": [
    "Data encryption in transit and at rest",
    "Access controls and user authentication",
    "Audit trails and logging",
    "Regular security assessments",
    "Compliance with industry security standards",
    "Incident response planning",
    "Data backup and recovery procedures",
    "Secure software development lifecycle",
    "Third-party security audits",
    "Security awareness training for staff"
  ],
  "privacy_features": [
    "Data anonymization and de-identification",
    "Patient consent management",
    "Data minimization practices",
    "Compliance with data protection regulations",
    "Secure data storage and transmission",
    "Access controls to protect patient information",
    "Regular privacy impact assessments",
    "Data retention policies",
    "Patient rights to access and control their data",
    "Third-party data sharing agreements"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "2021",
  "integration_partners": [],
  "id": "SW0463",
  "slug": "chest-cad",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/chest-cad.json"
  }
}