Koios DS Breast

JSON twin: https://www.healthaidb.com/software/koios-ds-breast.json

Company Name

Koios Medical

Product URL

https://koiosmedical.com/koios-ds-breast

Company URL

https://koiosmedical.com

Categories

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

Summary

Koios DS Breast is an AI-powered ultrasound software that assists physicians in early and accurate breast cancer diagnosis by analyzing ultrasound images and providing risk assessments.

Description

Koios DS Breast utilizes artificial intelligence and machine learning to analyze ultrasound images, offering decision support for breast cancer detection. It integrates with existing PACS workstations and ultrasound systems, providing automated lesion classification and BI-RADS alignment. The software has been FDA-cleared and CE-marked, demonstrating improved diagnostic accuracy and reduced benign biopsies in clinical studies.

Api Available

yes

Certifications

• FDA 510(k)
• CE mark

Company Founding

2007

Company Offices

• United States
• Germany
• Italy
• Spain
• Turkey
• United Kingdom
• Kenya
• South Africa
• Singapore
• Taiwan

Compliance

• FDA 510(k) clearance
• CE Mark
• HIPAA
• GDPR

Customers

Data Residency

US-hosted with cloud hosting options; transfers from EU to US (per vendor privacy/informed consent)

Data Standards

• DICOM
• HL7
• BI-RADS
• TI-RADS

Deployment Model

• SaaS
• on_prem

Features

• AI decision support for breast ultrasound
• Risk-of-malignancy scoring
• Image-level analysis (per selected ROI)
• Ensemble ML algorithms trained on proprietary image dataset
• Reduces unnecessary biopsies and follow-up
• BI-RADS / TI-RADS alignment
• Reports/decision support at point-of-care or via image viewer

Id

SW0131

Integration Partners

Integrations

• PACS workstations
• Reporting systems / EMR note export
• GE HealthCare (LOGIQ E10)
• GE HealthCare (Invenia ABUS)
• iCAD

Languages Supported

• English
• Spanish
• German
• French
• Italian
• Portuguese
• Chinese
• Japanese
• Korean
• Arabic
• Russian
• Turkish
• Hindi
• Swahili
• Thai
• Vietnamese
• Indonesian
• Tagalog
• Polish
• Dutch

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Thyroid analysis (Koios DS Thyroid product)

Os Platforms

• Web
• Windows

Pricing Details

Pricing based on annual diagnostic exam volume; contact vendor for details.

Pricing Model

subscription

Privacy Features

• Customer portal consent management
• Data transfer notifications (EU→US disclosures)

Product Code

SW0131

Product Name

Koios DS Breast

Ratings

Regions Available

• United States
• Europe
• Asia
• South America
• Africa

Related Urls

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

Release Year

Security Features

• Encrypted connections (TLS)
• Role-based access controls
• Audit logging

Specialties

• Radiology
• Oncology
• Medical Imaging

Support Channels

System Requirements

Connects to PACS/image viewers; web browser access; customer activation/installation per vendor playbook

Target Users

• clinicians
• radiologists
• technologists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Koios DS Breast",
  "company_name": "Koios Medical",
  "product_url": "https://koiosmedical.com/koios-ds-breast",
  "company_url": "https://koiosmedical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0131",
  "summary": "Koios DS Breast is an AI-powered ultrasound software that assists physicians in early and accurate breast cancer diagnosis by analyzing ultrasound images and providing risk assessments.",
  "description": "Koios DS Breast utilizes artificial intelligence and machine learning to analyze ultrasound images, offering decision support for breast cancer detection. It integrates with existing PACS workstations and ultrasound systems, providing automated lesion classification and BI-RADS alignment. The software has been FDA-cleared and CE-marked, demonstrating improved diagnostic accuracy and reduced benign biopsies in clinical studies.",
  "categories": [
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    "imaging Software",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "healthcare Software Solutions",
    "Clinical Decision Support",
    "Diagnostic Imaging",
    "Medical Imaging",
    "Artificial Intelligence",
    "Healthcare Software"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "radiologists",
    "technologists"
  ],
  "specialties": [
    "Radiology",
    "Oncology",
    "Medical Imaging"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Asia",
    "South America",
    "Africa"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "German",
    "French",
    "Italian",
    "Portuguese",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Russian",
    "Turkish",
    "Hindi",
    "Swahili",
    "Thai",
    "Vietnamese",
    "Indonesian",
    "Tagalog",
    "Polish",
    "Dutch"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Pricing based on annual diagnostic exam volume; contact vendor for details.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Germany",
    "Italy",
    "Spain",
    "Turkey",
    "United Kingdom",
    "Kenya",
    "South Africa",
    "Singapore",
    "Taiwan"
  ],
  "company_founding": "2007",
  "deployment_model": [
    "SaaS",
    "on_prem"
  ],
  "os_platforms": [
    "Web",
    "Windows"
  ],
  "features": [
    "AI decision support for breast ultrasound",
    "Risk-of-malignancy scoring",
    "Image-level analysis (per selected ROI)",
    "Ensemble ML algorithms trained on proprietary image dataset",
    "Reduces unnecessary biopsies and follow-up",
    "BI-RADS / TI-RADS alignment",
    "Reports/decision support at point-of-care or via image viewer"
  ],
  "optional_modules": [
    "Thyroid analysis (Koios DS Thyroid product)"
  ],
  "integrations": [
    "PACS workstations",
    "Reporting systems / EMR note export",
    "GE HealthCare (LOGIQ E10)",
    "GE HealthCare (Invenia ABUS)",
    "iCAD"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "BI-RADS",
    "TI-RADS"
  ],
  "api_available": "yes",
  "system_requirements": "Connects to PACS/image viewers; web browser access; customer activation/installation per vendor playbook",
  "compliance": [
    "FDA 510(k) clearance",
    "CE Mark",
    "HIPAA",
    "GDPR"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE mark"
  ],
  "security_features": [
    "Encrypted connections (TLS)",
    "Role-based access controls",
    "Audit logging"
  ],
  "privacy_features": [
    "Customer portal consent management",
    "Data transfer notifications (EU→US disclosures)"
  ],
  "data_residency": "US-hosted with cloud hosting options; transfers from EU to US (per vendor privacy/informed consent)",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0131",
  "slug": "koios-ds-breast",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/koios-ds-breast.json"
  }
}