FractureDetect

JSON twin: https://www.healthaidb.com/software/fracturedetect.json

Company Name

Imagen Technologies

Product URL

https://www.imagen-tech.com/solutions/fracturedetect

Company URL

https://www.imagen-tech.com

Categories

• clinical Care
• imaging Software
• radiology
• ai Clinical Documentation Integrity
• clinical Decision Support
• healthcare Software Solutions
• Clinical
• Diagnostic Imaging
• Artificial Intelligence
• Medical Software

Summary

FractureDetect is an AI-powered software developed by Imagen Technologies to assist clinicians in detecting fractures during the review of musculoskeletal radiographs in adults.

Description

FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device designed to aid clinicians in identifying fractures in adult patients by analyzing radiographs of the musculoskeletal system. Utilizing supervised deep learning, it processes DICOM images from standard imaging devices or DICOM nodes, providing a toggleable annotation overlay on the original image within a PACS system to highlight fractures. The device operates securely with HIPAA compliance and is intended as an adjunct tool, not a replacement for a clinician’s review of the radiograph or clinical judgment. It was granted FDA 510(k) clearance on July 30, 2020, demonstrating high sensitivity (95.1%) and specificity (89.3%) in detecting fractures across various anatomical regions. ([fda.report](https://fda.report/PMN/K193417?utm_source=openai))

Api Available

yes

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 13485

Company Founding

2016

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• SOC 2
• ISO 27001

Customers

Data Residency

US/EU regions

Data Standards

• HL7
• DICOM
• FHIR

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-powered fracture detection
• Real-time imaging analysis
• Automated reporting
• Integration with existing PACS systems
• User-friendly interface
• Scalable architecture
• Cloud-based storage
• HIPAA-compliant data handling
• Multi-language support
• Customizable alert thresholds

Id

SW0502

Integration Partners

Integrations

• PACS
• EHR
• RIS
• HL7
• DICOM
• FHIR

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Advanced analytics dashboard
• Mobile application
• Third-party EHR integration
• Patient portal
• Telemedicine integration

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• BAA available
• consent mgmt
• anonymization
• data minimization

Product Code

SW0502

Product Name

FractureDetect

Ratings

Regions Available

• United States

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

Specialties

• Orthopedics
• Emergency Medicine
• Radiology

Support Channels

System Requirements

Windows Server 2016+, 8 GB RAM, 100 GB storage

Target Users

• Clinicians
• Radiologists
• Orthopedic Surgeons
• Emergency Medicine Physicians
• Primary Care Physicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "FractureDetect",
  "company_name": "Imagen Technologies",
  "product_url": "https://www.imagen-tech.com/solutions/fracturedetect",
  "company_url": "https://www.imagen-tech.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0502",
  "summary": "FractureDetect is an AI-powered software developed by Imagen Technologies to assist clinicians in detecting fractures during the review of musculoskeletal radiographs in adults.",
  "description": "FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device designed to aid clinicians in identifying fractures in adult patients by analyzing radiographs of the musculoskeletal system. Utilizing supervised deep learning, it processes DICOM images from standard imaging devices or DICOM nodes, providing a toggleable annotation overlay on the original image within a PACS system to highlight fractures. The device operates securely with HIPAA compliance and is intended as an adjunct tool, not a replacement for a clinician’s review of the radiograph or clinical judgment. It was granted FDA 510(k) clearance on July 30, 2020, demonstrating high sensitivity (95.1%) and specificity (89.3%) in detecting fractures across various anatomical regions. ([fda.report](https://fda.report/PMN/K193417?utm_source=openai))",
  "categories": [
    "clinical Care",
    "imaging Software",
    "radiology",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "healthcare Software Solutions",
    "Clinical",
    "Diagnostic Imaging",
    "Radiology",
    "Artificial Intelligence",
    "Medical Software"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Radiologists",
    "Orthopedic Surgeons",
    "Emergency Medicine Physicians",
    "Primary Care Physicians"
  ],
  "specialties": [
    "Orthopedics",
    "Emergency Medicine",
    "Radiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2016",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "AI-powered fracture detection",
    "Real-time imaging analysis",
    "Automated reporting",
    "Integration with existing PACS systems",
    "User-friendly interface",
    "Scalable architecture",
    "Cloud-based storage",
    "HIPAA-compliant data handling",
    "Multi-language support",
    "Customizable alert thresholds"
  ],
  "optional_modules": [
    "Advanced analytics dashboard",
    "Mobile application",
    "Third-party EHR integration",
    "Patient portal",
    "Telemedicine integration"
  ],
  "integrations": [
    "PACS",
    "EHR",
    "RIS",
    "HL7",
    "DICOM",
    "FHIR"
  ],
  "data_standards": [
    "HL7",
    "DICOM",
    "FHIR"
  ],
  "api_available": "yes",
  "system_requirements": "Windows Server 2016+, 8 GB RAM, 100 GB storage",
  "compliance": [
    "HIPAA",
    "GDPR",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 13485"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "audit logs",
    "2FA"
  ],
  "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": "SW0502",
  "slug": "fracturedetect",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/fracturedetect.json"
  }
}