QuantX

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

Company Name

Quantitative Insights

Product URL

https://quantinsights.com

Company URL

https://quantinsights.com

Categories

• clinical Care
• imaging Software
• radiology
• ai Clinical Documentation Integrity
• clinical Decision Support
• medical Device
• Clinical
• Diagnostic Imaging
• Artificial Intelligence
• Medical Devices

Summary

QuantX is an FDA-cleared AI-driven software platform that assists radiologists in evaluating breast MRI images, enhancing diagnostic accuracy and efficiency.

Description

QuantX is a computer-aided diagnosis (CADx) system developed by Quantitative Insights, Inc., utilizing machine learning to analyze breast MRI images. It automates lesion segmentation and compares findings to a database of known cases, providing a QI Score to aid in diagnosis. The platform aims to improve radiologists' confidence, reduce costs, and enhance patient outcomes. It received FDA clearance in July 2017 and incorporates technology licensed from the University of Chicago's research labs.

Api Available

yes

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8

Company Founding

2010

Company Offices

• United States

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

Customers

Data Residency

US and EU regions

Data Standards

• DICOM
• HL7 v2
• FHIR
• SNOMED CT
• ICD-10
• LOINC
• CPT
• ICD-9
• NDC
• RxNorm

Deployment Model

• SaaS

Features

• AI-powered medical imaging analysis
• Automated detection of anomalies
• Quantitative assessment of imaging data
• Integration with existing PACS systems
• Real-time image processing
• User-friendly interface
• Cloud-based storage and access
• Regulatory compliance with FDA 510(k) clearance
• Continuous software updates and improvements
• Secure data transmission and storage
• Scalable architecture for healthcare institutions
• Customizable reporting tools
• Multi-language support
• Patient data anonymization
• Clinical decision support tools
• Integration with electronic health records (EHR)
• Remote access capabilities
• Audit trails for user activity
• Data visualization tools
• Collaboration features for medical teams

Id

SW0611

Integration Partners

Integrations

• PACS
• EHR
• LIS
• Wearable health devices
• Laboratory information systems
• Telemedicine platforms
• Clinical trial management systems
• Mobile health applications
• Voice recognition systems
• Cloud storage services

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• Healthcare Institutions
• Medical Imaging Centers

Optional Modules

• Advanced 3D imaging analysis
• Integration with laboratory information systems (LIS)
• Mobile app for patient engagement
• Telemedicine integration
• Predictive analytics for disease progression
• Patient outcome tracking
• Clinical trial support tools
• Integration with wearable health devices
• Natural language processing for medical records
• Voice command functionality

Os Platforms

• Web
• iOS
• Android

Pricing Details

Contact vendor for pricing information.

Pricing Model

Enterprise_Quote

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data residency options
• User data access controls
• Data retention policies
• Data breach notification procedures
• Third-party audits
• Privacy impact assessments

Product Code

SW0611

Product Name

QuantX

Ratings

Regions Available

• United States
• International

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
• Secure data transmission
• Data anonymization
• Access controls
• Regular security updates

Specialties

• Breast Imaging
• Radiology
• Medical Imaging
• Oncology

Support Channels

System Requirements

Web browser, iOS or Android device

Target Users

• Radiologists
• Medical Imaging Professionals
• Healthcare Providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "QuantX",
  "company_name": "Quantitative Insights",
  "product_url": "https://quantinsights.com",
  "company_url": "https://quantinsights.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0611",
  "summary": "QuantX is an FDA-cleared AI-driven software platform that assists radiologists in evaluating breast MRI images, enhancing diagnostic accuracy and efficiency.",
  "description": "QuantX is a computer-aided diagnosis (CADx) system developed by Quantitative Insights, Inc., utilizing machine learning to analyze breast MRI images. It automates lesion segmentation and compares findings to a database of known cases, providing a QI Score to aid in diagnosis. The platform aims to improve radiologists' confidence, reduce costs, and enhance patient outcomes. It received FDA clearance in July 2017 and incorporates technology licensed from the University of Chicago's research labs.",
  "categories": [
    "clinical Care",
    "imaging Software",
    "radiology",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "medical Device",
    "Clinical",
    "Diagnostic Imaging",
    "Radiology",
    "Artificial Intelligence",
    "Medical Devices"
  ],
  "market_segment": [
    "Enterprise",
    "Healthcare Institutions",
    "Medical Imaging Centers"
  ],
  "target_users": [
    "Radiologists",
    "Medical Imaging Professionals",
    "Healthcare Providers"
  ],
  "specialties": [
    "Breast Imaging",
    "Radiology",
    "Medical Imaging",
    "Oncology"
  ],
  "regions_available": [
    "United States",
    "International"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "Enterprise_Quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2010",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android"
  ],
  "features": [
    "AI-powered medical imaging analysis",
    "Automated detection of anomalies",
    "Quantitative assessment of imaging data",
    "Integration with existing PACS systems",
    "Real-time image processing",
    "User-friendly interface",
    "Cloud-based storage and access",
    "Regulatory compliance with FDA 510(k) clearance",
    "Continuous software updates and improvements",
    "Secure data transmission and storage",
    "Scalable architecture for healthcare institutions",
    "Customizable reporting tools",
    "Multi-language support",
    "Patient data anonymization",
    "Clinical decision support tools",
    "Integration with electronic health records (EHR)",
    "Remote access capabilities",
    "Audit trails for user activity",
    "Data visualization tools",
    "Collaboration features for medical teams"
  ],
  "optional_modules": [
    "Advanced 3D imaging analysis",
    "Integration with laboratory information systems (LIS)",
    "Mobile app for patient engagement",
    "Telemedicine integration",
    "Predictive analytics for disease progression",
    "Patient outcome tracking",
    "Clinical trial support tools",
    "Integration with wearable health devices",
    "Natural language processing for medical records",
    "Voice command functionality"
  ],
  "integrations": [
    "PACS",
    "EHR",
    "LIS",
    "Wearable health devices",
    "Laboratory information systems",
    "Telemedicine platforms",
    "Clinical trial management systems",
    "Mobile health applications",
    "Voice recognition systems",
    "Cloud storage services"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "FHIR",
    "SNOMED CT",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC",
    "RxNorm"
  ],
  "api_available": "yes",
  "system_requirements": "Web browser, iOS or Android device",
  "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"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Secure data transmission",
    "Data anonymization",
    "Access controls",
    "Regular security updates"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data residency options",
    "User data access controls",
    "Data retention policies",
    "Data breach notification procedures",
    "Third-party audits",
    "Privacy impact assessments"
  ],
  "data_residency": "US and EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0611",
  "slug": "quantx",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/quantx.json"
  }
}