HealthMammo

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

Company Name

Zebra Medical Vision

Product URL

https://www.zebra-med.com/healthmammo

Company URL

https://www.zebra-med.com

Categories

• diagnostic Support
• clinical Care
• administrative Operations
• Diagnostic
• Clinical
• Administrative

Summary

HealthMammo is an AI-driven tool that assists radiologists in prioritizing and identifying suspicious findings in 2D mammograms, enhancing early breast cancer detection.

Description

HealthMammo is an AI-based software developed by Zebra Medical Vision to analyze 2D full-field digital mammograms, flagging suspicious findings to aid radiologists in prioritizing cases. It integrates with existing radiology workflows, providing passive notifications within the PACS/worklist to improve efficiency without replacing diagnostic evaluation. The tool has received FDA 510(k) clearance and a CE mark, demonstrating its regulatory compliance and readiness for clinical use.

Api Available

yes

Certifications

• FDA 510(k)
• CE mark
• ISO 13485
• ISO 14971
• ISO 27001
• SOC 2 Type 2
• FDA 21 CFR Part 820
• ISO 9001
• ISO 14001
• ISO 45001

Company Founding

2014

Company Offices

• Israel
• United States
• Europe

Compliance

• HIPAA
• GDPR
• FDA 510(k)
• CE mark
• ISO 13485
• ISO 14971
• ISO 27001
• SOC 2 Type 2
• HITECH
• FDA 21 CFR Part 820

Customers

Data Residency

US/EU regions

Data Standards

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

Deployment Model

• SaaS

Features

• Automated AI analysis of 2D mammograms
• Prioritization and detection of suspicious mammograms
• Integration with PACS systems
• Support for breast radiologists in reading and reporting workflows
• FDA 510(k) clearance for mammography solution
• CE mark approval in Europe
• Part of Zebra Medical's AI1 (All-In-One) bundle
• Processing and analysis of suspected breast lesions
• Signal notifications within worklist or dedicated application
• Improved patient care through comprehensive reporting
• Enhanced diagnostic accuracy for breast cancer detection
• Real-time analysis of mammography images
• Seamless integration with existing radiology workflows
• Scalable deployment across multiple healthcare facilities
• Continuous updates and improvements to AI algorithms
• User-friendly interface for radiologists
• Secure handling of patient data
• Compliance with healthcare data security standards
• Support for various mammography equipment vendors
• Ability to handle large volumes of mammography data

Id

SW0503

Integration Partners

Integrations

• PACS systems
• Electronic health records (EHR)
• Mammography equipment vendors
• Telemedicine platforms
• Cloud-based storage solutions
• Other imaging modalities
• Patient management systems
• Clinical decision support systems
• Mobile applications for radiologists
• Third-party analytics platforms

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Advanced analytics dashboard
• Integration with electronic health records (EHR)
• Support for 3D mammography images
• Automated reporting generation
• Integration with other imaging modalities
• Patient management features
• Clinical decision support tools
• Integration with telemedicine platforms
• Mobile application for radiologists
• Cloud-based storage solutions

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data residency options
• Data access controls
• Data retention policies
• User data rights management
• Compliance with data protection laws
• Regular privacy audits

Product Code

SW0503

Product Name

HealthMammo

Ratings

Regions Available

• United States
• Europe

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 assessments

Specialties

• Oncology
• Radiology

Support Channels

System Requirements

Target Users

• radiologists
• clinicians
• healthcare providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "HealthMammo",
  "company_name": "Zebra Medical Vision",
  "product_url": "https://www.zebra-med.com/healthmammo",
  "company_url": "https://www.zebra-med.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0503",
  "summary": "HealthMammo is an AI-driven tool that assists radiologists in prioritizing and identifying suspicious findings in 2D mammograms, enhancing early breast cancer detection.",
  "description": "HealthMammo is an AI-based software developed by Zebra Medical Vision to analyze 2D full-field digital mammograms, flagging suspicious findings to aid radiologists in prioritizing cases. It integrates with existing radiology workflows, providing passive notifications within the PACS/worklist to improve efficiency without replacing diagnostic evaluation. The tool has received FDA 510(k) clearance and a CE mark, demonstrating its regulatory compliance and readiness for clinical use.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "administrative Operations",
    "Diagnostic",
    "Clinical",
    "Administrative"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "radiologists",
    "clinicians",
    "healthcare providers"
  ],
  "specialties": [
    "Oncology",
    "Radiology"
  ],
  "regions_available": [
    "United States",
    "Europe"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "Israel",
    "United States",
    "Europe"
  ],
  "company_founding": "2014",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Automated AI analysis of 2D mammograms",
    "Prioritization and detection of suspicious mammograms",
    "Integration with PACS systems",
    "Support for breast radiologists in reading and reporting workflows",
    "FDA 510(k) clearance for mammography solution",
    "CE mark approval in Europe",
    "Part of Zebra Medical's AI1 (All-In-One) bundle",
    "Processing and analysis of suspected breast lesions",
    "Signal notifications within worklist or dedicated application",
    "Improved patient care through comprehensive reporting",
    "Enhanced diagnostic accuracy for breast cancer detection",
    "Real-time analysis of mammography images",
    "Seamless integration with existing radiology workflows",
    "Scalable deployment across multiple healthcare facilities",
    "Continuous updates and improvements to AI algorithms",
    "User-friendly interface for radiologists",
    "Secure handling of patient data",
    "Compliance with healthcare data security standards",
    "Support for various mammography equipment vendors",
    "Ability to handle large volumes of mammography data"
  ],
  "optional_modules": [
    "Advanced analytics dashboard",
    "Integration with electronic health records (EHR)",
    "Support for 3D mammography images",
    "Automated reporting generation",
    "Integration with other imaging modalities",
    "Patient management features",
    "Clinical decision support tools",
    "Integration with telemedicine platforms",
    "Mobile application for radiologists",
    "Cloud-based storage solutions"
  ],
  "integrations": [
    "PACS systems",
    "Electronic health records (EHR)",
    "Mammography equipment vendors",
    "Telemedicine platforms",
    "Cloud-based storage solutions",
    "Other imaging modalities",
    "Patient management systems",
    "Clinical decision support systems",
    "Mobile applications for radiologists",
    "Third-party analytics platforms"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC",
    "HCPCS"
  ],
  "api_available": "yes",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "GDPR",
    "FDA 510(k)",
    "CE mark",
    "ISO 13485",
    "ISO 14971",
    "ISO 27001",
    "SOC 2 Type 2",
    "HITECH",
    "FDA 21 CFR Part 820"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE mark",
    "ISO 13485",
    "ISO 14971",
    "ISO 27001",
    "SOC 2 Type 2",
    "FDA 21 CFR Part 820",
    "ISO 9001",
    "ISO 14001",
    "ISO 45001"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Secure data transmission",
    "Data anonymization",
    "Access controls",
    "Regular security assessments"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data residency options",
    "Data access controls",
    "Data retention policies",
    "User data rights management",
    "Compliance with data protection laws",
    "Regular privacy audits"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0503",
  "slug": "healthmammo",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/healthmammo.json"
  }
}