JSON twin: https://www.healthaidb.com/software/koios-ds-d3c996.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 risk stratification (BI-RADS / TI-RADS) and lesion descriptors.
Koios DS is a CE-marked and FDA 510(k)-cleared AI/ML medical software platform (Koios Smart Ultrasound) that analyzes still ultrasound images to segment lesions/nodules, auto-populate lexicon descriptors, and generate malignancy risk scores aligned to BI-RADS and ACR TI‑RADS; deployed on-scanner, in PACS/workflow, or as a virtualized/local solution to aid interpreting physicians and reduce unnecessary biopsies and follow-ups.
yes
2012
US-hosted with cloud hosting options; transfers from EU to US (per vendor privacy/informed consent)
P1882
2025-09-07
commercial proprietary
subscription-based (priced by number of analyses and/or users); contact vendor for quotes and trials
subscription
2021
Connects to PACS/image viewers; web browser access; customer activation/installation per vendor playbook
product
1.0
{
"company_name": "Koios Medical",
"company_url": "https://koiosmedical.com/",
"company_offices": [
"United States"
],
"company_founding": "2012",
"product_url": "https://koiosmedical.com/products/koios-ds-breast/",
"categories": [
"clinical",
"diagnostic",
"imaging",
"decision support",
"ai/ml"
],
"market_segment": [
"enterprise",
"healthcare provider"
],
"links": [
"https://koiosmedical.com/",
"https://koiosmedical.com/products/",
"https://koiosmedical.com/products/koios-ds-breast/",
"https://koiosmedical.com/products/koios-ds-thyroid/",
"https://koiosmedical.com/about/",
"https://koiosmedical.com/contact/",
"https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212616.pdf",
"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190442",
"https://healthairegister.com/companies/koios-medical-inc",
"https://pmc.ncbi.nlm.nih.gov/pmc/articles/PMC9955683/"
],
"summary": "AI-based ultrasound decision-support software that analyzes breast and thyroid ultrasound images to provide risk stratification (BI-RADS / TI-RADS) and lesion descriptors.",
"description": "Koios DS is a CE-marked and FDA 510(k)-cleared AI/ML medical software platform (Koios Smart Ultrasound) that analyzes still ultrasound images to segment lesions/nodules, auto-populate lexicon descriptors, and generate malignancy risk scores aligned to BI-RADS and ACR TI‑RADS; deployed on-scanner, in PACS/workflow, or as a virtualized/local solution to aid interpreting physicians and reduce unnecessary biopsies and follow-ups.",
"target_users": [
"radiologists",
"sonographers/ultrasound technicians",
"breast/thyroid clinicians",
"interpreting physicians",
"clinical administrators",
"researchers"
],
"specialties": [
"breast",
"thyroid"
],
"regions_available": [
"United States",
"United Kingdom",
"Germany",
"Italy",
"Spain",
"Turkey",
"Netherlands",
"Singapore",
"Taiwan",
"Kuwait",
"Qatar",
"Saudi Arabia",
"United Arab Emirates",
"Argentina",
"Brazil",
"Chile",
"Mexico",
"Peru",
"Kenya",
"South Africa"
],
"languages_supported": [
"English"
],
"pricing_model": "subscription",
"pricing_details": "subscription-based (priced by number of analyses and/or users); contact vendor for quotes and trials",
"license": "commercial proprietary",
"deployment_model": [
"SaaS",
"on_prem"
],
"os_platforms": [
"Web",
"Windows"
],
"features": [
"AI decision support for breast ultrasound",
"AI decision support for thyroid 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": [
"Breast module",
"Thyroid module"
],
"integrations": [
"PACS / image viewers",
"GE Healthcare (LOGIQ integration / on-demand second opinion)",
"Hospital imaging workflows / viewers"
],
"data_standards": [
"DICOM",
"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"
],
"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": [
"email",
"phone",
"ticketing",
"community"
],
"training_options": [
"documentation",
"webinars",
"live_online",
"onsite"
],
"release_year": "2021",
"integration_partners": [
"GE Healthcare (Edison platform)",
"iCAD",
"Alma Health Platform",
"Amplify SDK",
"RMS Medical Devices",
"PACS vendors (unnamed)"
],
"id": "P1882",
"slug": "koios-ds-d3c996",
"type": "product",
"version": "1.0",
"last_updated": "2025-09-07",
"links_json": {
"self": "https://www.healthaidb.com/software/koios-ds-d3c996.json"
}
}