{"product_name":"icobrain-ctp","company_name":"icometrix","product_url":"https://www.icometrix.com/icobrain-ctp","company_url":"https://www.icometrix.com/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0520","summary":"icobrain-ctp is an AI-driven software by icometrix that analyzes CT perfusion scans to assess brain tissue perfusion, aiding in stroke evaluation and management.","description":"icobrain-ctp is an FDA-cleared and CE-marked software designed to process CT perfusion scans of the brain. It calculates tissue perfusion parameters and identifies volumes affected by abnormalities, providing detailed reports to assist clinicians in stroke assessment and decision-making. The software integrates with standard radiological viewing platforms and exports CT perfusion parameter maps in DICOM format, facilitating efficient and informed clinical decisions.","categories":["diagnostic Support","clinical Care","administrative Operations","Diagnostic","Clinical","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","neurologists"],"specialties":["Neurology","Radiology","Stroke Care"],"regions_available":["United States","European Union","Canada","Australia","South America"],"languages_supported":["English","Dutch","French","German","Spanish"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Belgium","United States"],"company_founding":"2011","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","Windows","Linux"],"features":["Automated brain MRI quantification","Longitudinal comparison and trending","Lesion detection and volumetrics","Brain atrophy measurement and regional volumes","ARIA detection and grading","Stroke lesion and perfusion quantification","Tumor core/resection cavity/edema tracking","TBI structural change quantification","Epilepsy abnormality pattern support","Interactive structured clinical reports","CPT code/reimbursement support","Vendor-agnostic PACS/RIS/EMR integration","Batch processing and study queuing","Clinical decision support metrics and visualizations","Quality control and validation tools"],"optional_modules":["icobridge on-prem appliance","Extended reporting templates/custom templates","Regulatory/security documentation pack (MDS2, CAIQ)","Data processing/privacy agreement templates (DPA/BAA)"],"integrations":["PACS","RIS","EMR/EHR","Epic","Cerner","Philips","Siemens Healthineers","GE Healthcare","Sectra","Agfa","Radiology viewers","Billing systems (for CPT processing)","Clinical registries/research platforms"],"data_standards":["DICOM","HL7 v2","FHIR","SNOMED CT","ICD-10"],"api_available":"yes","system_requirements":"icobridge appliance (on-prem Linux-based gateway) or icometrix cloud; DICOM-capable scanners/PACS; hospital network connectivity","compliance":["HIPAA","GDPR","HITECH","ISO 27001","ISO 13485","MDSAP"],"certifications":["FDA clearance (multiple solutions)","CE mark (NB1639)","ISO 13485","ISO 27001","MDSAP"],"security_features":["Data encryption at rest and in transit","Role-based access control (RBAC)","Single sign-on (SSO) / SAML","Audit logging and traceability","Vulnerability reporting process"],"privacy_features":["Business Associate Agreement (BAA) available","Data anonymization/de-identification options","Data minimization for research exports","Privacy policy and cookie controls"],"data_residency":"US and EU hosting options (regional cloud hosting available)","customers":[],"user_reviews":[],"ratings":["4.5 out of 5 on G2"],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0520","slug":"icobrain-ctp","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/icobrain-ctp.json"}}