JSON twin: https://www.healthaidb.com/software/koios-ds.json
Koios Medical
https://koiosmedical.com/products/koios-ds-breast/
AI-based ultrasound decision-support software that analyzes breast and thyroid ultrasound images to provide malignancy risk scores and structured lesion descriptors.
Koios DS (SmartUltrasound) is a regulatory-cleared AI medical software that analyzes user-selected regions on breast and thyroid ultrasound images, captures quantitative nodule descriptors, aligns results to BI-RADS/TI-RADS/ATA, and returns malignancy risk scores and structured outputs for reporting and PACS capture. The platform is trained on millions of ultrasound images and is intended as decision support for interpreting physicians to improve sensitivity, specificity, and consistency while reducing unnecessary biopsies and interpretation time.
unknown
2007
US-based cloud hosting with transfers from EU to US; hosted on leading cloud providers (customer portal)
P0900
2025-09-07
commercial (proprietary)
Contact vendor for pricing, licensing and deployment options; activation/onboarding support available.
enterprise_quote
2019
Installation/activation playbook provided; integrates with PACS workstations; cloud-hosted customer portal (no explicit OS/DB listed)
product
1.0
{
"company_name": "Koios Medical",
"company_url": "https://koiosmedical.com",
"company_offices": [
"United States"
],
"company_founding": "2007",
"product_url": "https://koiosmedical.com/products/koios-ds-breast/",
"categories": [
"clinical",
"diagnostic",
"imaging",
"decision support",
"AI/ML",
"radiology"
],
"market_segment": [
"enterprise",
"healthcare providers",
"radiology practices"
],
"links": [
"https://koiosmedical.com/products/koios-ds-breast/",
"https://koiosmedical.com/products/koios-ds-thyroid/",
"https://koiosmedical.com/about/",
"https://koiosmedical.com/research/",
"https://accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190442",
"https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212616.pdf",
"https://elion.health/products/koios-ds",
"https://www.gehealthcare.com/en-sg/insights/article/improving-clinical-outcomes-within-ultrasound%E2%80%99s-digital-ecosystem",
"https://koiosmedical.com/activate-now/"
],
"summary": "AI-based ultrasound decision-support software that analyzes breast and thyroid ultrasound images to provide malignancy risk scores and structured lesion descriptors.",
"description": "Koios DS (SmartUltrasound) is a regulatory-cleared AI medical software that analyzes user-selected regions on breast and thyroid ultrasound images, captures quantitative nodule descriptors, aligns results to BI-RADS/TI-RADS/ATA, and returns malignancy risk scores and structured outputs for reporting and PACS capture. The platform is trained on millions of ultrasound images and is intended as decision support for interpreting physicians to improve sensitivity, specificity, and consistency while reducing unnecessary biopsies and interpretation time.",
"target_users": [
"radiologists",
"sonographers",
"breast surgeons",
"endocrinologists",
"ambulatory clinic physicians",
"hospital administrators"
],
"specialties": [
"breast imaging",
"thyroid imaging",
"diagnostic radiology",
"ultrasound"
],
"regions_available": [
"United States",
"European Union",
"United Kingdom",
"Australia",
"Japan",
"China"
],
"languages_supported": [
"English"
],
"pricing_model": "enterprise_quote",
"pricing_details": "Contact vendor for pricing, licensing and deployment options; activation/onboarding support available.",
"license": "commercial (proprietary)",
"features": [
"AI-powered breast ultrasound lesion analysis and malignancy risk scoring",
"Automated extraction of nodule descriptors",
"Aligns outputs to BI-RADS and ATA ratings",
"Generates cancer risk score in seconds",
"Secondary capture images saved to PACS",
"Export findings to reporting systems / EMR",
"CPT-billable procedure support (CPT codes provided)",
"Decision support to reduce inter-/intra-observer variability",
"Clinical study–backed performance (AJR study cited)",
"Trained on proprietary image corpus (~2M images, ~17k features per image)"
],
"integrations": [
"PACS workstations",
"Reporting systems / EMR note export",
"iCAD (partner/integration mentioned)"
],
"deployment_model": [
"on_prem",
"cloud"
],
"os_platforms": [
"Web",
"Windows"
],
"optional_modules": [
"Thyroid analysis (Koios DS Thyroid product)"
],
"data_standards": [
"DICOM",
"HL7"
],
"api_available": "unknown",
"system_requirements": "Installation/activation playbook provided; integrates with PACS workstations; cloud-hosted customer portal (no explicit OS/DB listed)",
"compliance": [
"HIPAA",
"GDPR"
],
"certifications": [
"FDA 510(k) clearance",
"CE Mark"
],
"security_features": [
"Encrypted connections (in transit)",
"Role-limited staff access / access controls",
"Audit logging / usage tracking"
],
"privacy_features": [
"Customer portal consent management",
"Data retention policy for portal data (retained, deletion workflow)",
"EU→US transfer disclosure"
],
"data_residency": "US-based cloud hosting with transfers from EU to US; hosted on leading cloud providers (customer portal)",
"customers": [
"Liberty Hospital (MO)",
"GE HealthCare",
"Mitsui & Co.",
"iCAD",
"Clearview Diagnostics (early developer of Koios DS)"
],
"user_reviews": [],
"ratings": [
"FDA 510(k) clearance (U.S. FDA, 2019)",
"CE Mark (European Union)",
"Positive coverage in Applied Radiology (trade press)"
],
"support_channels": [
"email",
"phone",
"chat",
"ticketing",
"community"
],
"training_options": [
"documentation",
"webinars",
"live_online",
"onsite",
"training_via_partner"
],
"release_year": "2019",
"integration_partners": [
"GE HealthCare (LOGIQ E10)",
"GE HealthCare (Invenia ABUS)",
"Major PACS/workstation platforms",
"iCAD",
"PACS/viewer vendors (unnamed)"
],
"id": "P0900",
"slug": "koios-ds",
"type": "product",
"version": "1.0",
"last_updated": "2025-09-07",
"links_json": {
"self": "https://www.healthaidb.com/software/koios-ds.json"
}
}