JSON twin: https://www.healthaidb.com/software/annalise-enterprise-ctb.json
Annalise AI
https://annalise.ai/annalise-enterprise-ctb/
AI clinical decision‑support and triage tool that analyses non‑contrast head CTs (NCCTB) to detect and prioritise up to 130 acute and chronic intracranial findings for radiologists and clinical teams.
Annalise Enterprise CTB is a medical‑device software solution that automatically analyses non‑contrast head CT studies (adult patients) to indicate presence of findings, provide segmentation overlays, confidence scores and worklist triage/notifications. It supports integration with PACS/RIS, HL7/API worklist outputs and can be deployed cloud, hybrid or on‑premises (VM/Docker). Regulatory clearances include FDA 510(k) and CE (MDR Class IIb); it is marketed in 40+ countries and used by hundreds of clinical sites.
yes
2019
Region-specific hosting options (US, EU, AU / vendor supports local/regional deployments and cloud or on-prem container hosting)
P1913
2025-09-07
commercial proprietary
subscription-based, priced by number of analyses; contact vendor for commercial tiers and quotes
subscription
2023
Supports cloud SaaS or on-prem/container deployment; Linux-based server/container runtime; DICOM connectivity to PACS/RIS; (detailed HW/DB specs provided in vendor admin guide)
product
1.0
{
"company_name": "Annalise AI",
"company_url": "https://annalise.ai/",
"company_offices": [
"Australia",
"United Kingdom",
"United States",
"India",
"Netherlands"
],
"company_founding": "2019",
"product_url": "https://annalise.ai/annalise-enterprise-ctb/",
"categories": [
"clinical",
"diagnostic",
"radiology",
"medical imaging",
"decision-support",
"triage",
"AI"
],
"market_segment": [
"enterprise"
],
"links": [
"https://annalise.ai/annalise-enterprise-ctb/",
"https://annalise.ai/about-us/",
"https://annalise.ai/wp-content/uploads/2025/06/OPT-PRM-027-Annalise-Enterprise-User-Guide-11.pdf",
"https://support.annalise.ai/",
"https://healthairegister.com/products/annalise-ctb",
"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223240",
"https://mearis.cms.gov/public/publications/ntap/NTP231017D5AA7",
"https://appsource.microsoft.com/en-us/product/web-apps/annalise-aiptyltd1713829266693.annalise_enterprise_cxr?tab=overview"
],
"summary": "AI clinical decision‑support and triage tool that analyses non‑contrast head CTs (NCCTB) to detect and prioritise up to 130 acute and chronic intracranial findings for radiologists and clinical teams.",
"description": "Annalise Enterprise CTB is a medical‑device software solution that automatically analyses non‑contrast head CT studies (adult patients) to indicate presence of findings, provide segmentation overlays, confidence scores and worklist triage/notifications. It supports integration with PACS/RIS, HL7/API worklist outputs and can be deployed cloud, hybrid or on‑premises (VM/Docker). Regulatory clearances include FDA 510(k) and CE (MDR Class IIb); it is marketed in 40+ countries and used by hundreds of clinical sites.",
"target_users": [
"radiologists",
"emergency physicians",
"neuroradiologists",
"radiology technologists",
"hospital administrators",
"PACS/RIS administrators"
],
"specialties": [
"neuro/radiology",
"emergency medicine"
],
"regions_available": [
"Australia",
"United Kingdom",
"United States",
"New Zealand",
"Singapore",
"European Union",
"Other international markets (40+ countries)"
],
"languages_supported": [
"English"
],
"pricing_model": "subscription",
"pricing_details": "subscription-based, priced by number of analyses; contact vendor for commercial tiers and quotes",
"license": "commercial proprietary",
"deployment_model": [
"SaaS",
"on_prem",
"container"
],
"os_platforms": [
"Web",
"Linux (server/container)"
],
"features": [
"AI detection of up to 130 findings on non-contrast head CT (NCCTB)",
"Automated triage/prioritization of urgent cases (worklist flagging)",
"Localization and visual overlays/heatmaps of suspected findings",
"Per-finding confidence scores",
"Rapid analysis (designed for results in ~2 minutes or less)",
"Structured outputs to support reporting workflows",
"Case-level metadata and prioritization tags for workflow routing",
"Notification/alerting to care teams for time-sensitive findings",
"Supports unattended batch or real-time study analysis",
"Validated clinically with peer-reviewed evidence and trials"
],
"optional_modules": [
"Triage Trauma module (Annalise Enterprise CTB Triage - Trauma)",
"Obstructive Hydrocephalus detection/NTAP-enabled pathway"
],
"integrations": [
"Nuance (workflow/reporting integration)",
"Sectra (marketplace/container deployment references)",
"Blackford/third‑party AI service catalogs/marketplaces",
"PACS (DICOM-based integration)",
"RIS/worklist systems",
"VNA/archive systems",
"EHR workflow integration via reporting/worklist partners (e.g., Epic via workflow partners)"
],
"data_standards": [
"DICOM",
"DICOM SR",
"HL7 v2",
"FHIR"
],
"api_available": "yes",
"system_requirements": "Supports cloud SaaS or on-prem/container deployment; Linux-based server/container runtime; DICOM connectivity to PACS/RIS; (detailed HW/DB specs provided in vendor admin guide)",
"compliance": [
"FDA 510(k) cleared products (see K-number listings)",
"CE mark (EU) / European regulatory approvals",
"Singapore HSA registration/approval",
"Australian regulatory listings (TGA references)",
"Information security management (BSI/ISO27001 scope indicated)"
],
"certifications": [
"FDA 510(k) (K231094 / K223240 references)",
"CE mark",
"Singapore regulatory approval",
"BSI Information Security Management certification",
"Medical Devices Quality Management certification"
],
"security_features": [
"Role-based access control (RBAC)",
"Audit logging",
"Encryption in transit (TLS)",
"Encryption at rest"
],
"privacy_features": [
"BAA/enterprise data processing agreements available",
"Configurable data sharing/consent controls",
"Support for de-identification/anonymization for research workflows"
],
"data_residency": "Region-specific hosting options (US, EU, AU / vendor supports local/regional deployments and cloud or on-prem container hosting)",
"customers": [
"I-MED Radiology (Australia)",
"Aarthi Scans (India)",
"NHS Trusts (UK)"
],
"user_reviews": [
"Improved radiologists' accuracy by 32% and reduced overall reading time by 11%.",
"Analyzes brain CTs as they are acquired and prioritises urgent cases for reporting.",
"Detects up to 130 distinct findings on non-contrast head CT studies, enabling broader clinical utility than single-finding tools.",
"Was one of the only clinical tools evaluated to perform comparably to consensus neuroradiologist interpretations for several hemorrhage subtypes in independent studies."
],
"ratings": [
"NTAP approval / CMS New Technology Add-on Payment (2024) - Centers for Medicare & Medicaid Services",
"AJNR / peer-reviewed evaluations reporting comparable performance to consensus neuroradiologists (peer-reviewed journal)"
],
"support_channels": [
"email",
"phone",
"webinars",
"ticketing",
"onsite"
],
"training_options": [
"documentation",
"webinars",
"live_online training",
"onsite training",
"onboarding materials"
],
"release_year": "2023",
"integration_partners": [
"Amazon Web Services (AWS)",
"Nuance (Precision Imaging Network)",
"Microsoft (AppSource listing)",
"Philips (evaluation/partnership activity)",
"PACS/RIS vendors (integrations with reporting workstations)",
"Harrison.ai (parent/technology partner)"
],
"id": "P1913",
"slug": "annalise-enterprise-ctb",
"type": "product",
"version": "1.0",
"last_updated": "2025-09-07",
"links_json": {
"self": "https://www.healthaidb.com/software/annalise-enterprise-ctb.json"
}
}