CINA-CSpine

JSON twin: https://www.healthaidb.com/software/cina-cspine.json

Company Name

Avicenna.AI

Product URL

https://avicenna.ai/solutions/spine/cina-cspine

Company URL

https://avicenna.ai

Categories

• clinical Care
• diagnostic Support
• radiology
• imaging Software
• clinical Decision Support
• Clinical
• Diagnostic
• Emergency Imaging
• Incidental Findings Detection

Summary

CINA-CSpine is an AI tool developed by Avicenna.AI to automatically detect and prioritize cervical spine fractures in CT scans, enhancing diagnostic efficiency and patient outcomes.

Description

CINA-CSpine is an AI-powered solution designed to support the detection and triage of cervical spine fractures from CT images. It was validated on over 300 non-contrast CT scans from multiple sources in the U.S. and Europe, achieving an overall sensitivity of 90.3% and specificity of 91.9%. The tool seamlessly integrates into radiologists' existing workflows, automatically triggering and reporting algorithm results through their systems. CINA-CSpine received FDA clearance in September 2024 and CE Mark certification in May 2025, enabling deployment across the U.S. and European Economic Area. The product is part of Avicenna.AI's suite of AI tools aimed at improving diagnostic accuracy and workflow efficiency in radiology. ([avicenna.ai](https://avicenna.ai/avicenna-ai-lands-fda-clearance-for-ai-tool-for-cervical-spine-fracture-detection/?utm_source=openai))

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE Mark
• MDR compliance
• ISO 13485
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• 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

Company Founding

2018

Company Offices

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

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• MDR 2017/745
• FDA 21 CFR Part 820
• ISO 13485
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• 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

Customers

Data Residency

EU-only, US/EU regions, BYO cloud region

Data Standards

• DICOM

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Cervical spine fracture detection
• Automated triage and prioritization
• Integration with PACS and RIS systems
• Cloud-based deployment
• Real-time analysis post-image acquisition
• Processing time: 1-10 minutes
• FDA 510(k) clearance
• CE Mark certification
• MDR compliance
• Integration with AI marketplaces
• Standalone third-party application support
• DICOM input and output formats
• Single MIP DICOM slice output
• Sensitivity: 90.3%
• Specificity: 91.9%
• Validated on over 300 non-contrast CT scans
• Compatible with 36 scanner models from five vendors
• Subscription-based pricing model
• Pricing based on number of users and installations

Id

SW0161

Integration Partners

Integrations

• PACS
• RIS
• AI marketplaces
• Third-party applications

Languages Supported

• English
• French
• German
• Spanish
• Italian
• Dutch
• Portuguese
• Swedish
• Danish
• Norwegian
• Finnish
• Polish
• Czech
• Hungarian
• Romanian
• Bulgarian
• Greek
• Slovak
• Slovenian
• Croatian

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Advanced analytics
• Customizable reporting
• Integration with additional RIS/PACS systems
• Multi-language support
• Advanced image processing algorithms
• Clinical decision support tools
• Patient data management
• Mobile application support
• Cloud storage options
• Data visualization tools

Os Platforms

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

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0161

Product Name

CINA-CSpine

Ratings

Regions Available

• United States
• European Economic Area

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

• Orthopedics
• Trauma Surgery
• Emergency Medicine
• Radiology

Support Channels

System Requirements

Dedicated hardware, Virtual machine, Docker, Cloud-based infrastructure

Target Users

• Radiologists
• Healthcare Professionals
• Clinicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "CINA-CSpine",
  "company_name": "Avicenna.AI",
  "product_url": "https://avicenna.ai/solutions/spine/cina-cspine",
  "company_url": "https://avicenna.ai",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0161",
  "summary": "CINA-CSpine is an AI tool developed by Avicenna.AI to automatically detect and prioritize cervical spine fractures in CT scans, enhancing diagnostic efficiency and patient outcomes.",
  "description": "CINA-CSpine is an AI-powered solution designed to support the detection and triage of cervical spine fractures from CT images. It was validated on over 300 non-contrast CT scans from multiple sources in the U.S. and Europe, achieving an overall sensitivity of 90.3% and specificity of 91.9%. The tool seamlessly integrates into radiologists' existing workflows, automatically triggering and reporting algorithm results through their systems. CINA-CSpine received FDA clearance in September 2024 and CE Mark certification in May 2025, enabling deployment across the U.S. and European Economic Area. The product is part of Avicenna.AI's suite of AI tools aimed at improving diagnostic accuracy and workflow efficiency in radiology. ([avicenna.ai](https://avicenna.ai/avicenna-ai-lands-fda-clearance-for-ai-tool-for-cervical-spine-fracture-detection/?utm_source=openai))",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "radiology",
    "imaging Software",
    "clinical Decision Support",
    "Clinical",
    "Diagnostic",
    "Radiology",
    "Emergency Imaging",
    "Incidental Findings Detection"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Radiologists",
    "Healthcare Professionals",
    "Clinicians"
  ],
  "specialties": [
    "Orthopedics",
    "Trauma Surgery",
    "Emergency Medicine",
    "Radiology"
  ],
  "regions_available": [
    "United States",
    "European Economic Area"
  ],
  "languages_supported": [
    "English",
    "French",
    "German",
    "Spanish",
    "Italian",
    "Dutch",
    "Portuguese",
    "Swedish",
    "Danish",
    "Norwegian",
    "Finnish",
    "Polish",
    "Czech",
    "Hungarian",
    "Romanian",
    "Bulgarian",
    "Greek",
    "Slovak",
    "Slovenian",
    "Croatian"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "France",
    "United States",
    "Germany",
    "United Kingdom",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Sweden",
    "Switzerland"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Cervical spine fracture detection",
    "Automated triage and prioritization",
    "Integration with PACS and RIS systems",
    "Cloud-based deployment",
    "Real-time analysis post-image acquisition",
    "Processing time: 1-10 minutes",
    "FDA 510(k) clearance",
    "CE Mark certification",
    "MDR compliance",
    "Integration with AI marketplaces",
    "Standalone third-party application support",
    "DICOM input and output formats",
    "Single MIP DICOM slice output",
    "Sensitivity: 90.3%",
    "Specificity: 91.9%",
    "Validated on over 300 non-contrast CT scans",
    "Compatible with 36 scanner models from five vendors",
    "Subscription-based pricing model",
    "Pricing based on number of users and installations"
  ],
  "optional_modules": [
    "Advanced analytics",
    "Customizable reporting",
    "Integration with additional RIS/PACS systems",
    "Multi-language support",
    "Advanced image processing algorithms",
    "Clinical decision support tools",
    "Patient data management",
    "Mobile application support",
    "Cloud storage options",
    "Data visualization tools"
  ],
  "integrations": [
    "PACS",
    "RIS",
    "AI marketplaces",
    "Third-party applications"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "Dedicated hardware, Virtual machine, Docker, Cloud-based infrastructure",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "MDR 2017/745",
    "FDA 21 CFR Part 820",
    "ISO 13485",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "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"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE Mark",
    "MDR compliance",
    "ISO 13485",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "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"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "EU-only, US/EU regions, BYO cloud region",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0161",
  "slug": "cina-cspine",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/cina-cspine.json"
  }
}