{"product_name":"DeepCT","company_name":"Deep01","product_url":"https://deep01.com/deepct","company_url":"https://deep01.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0552","summary":"DeepCT is an AI-powered software developed by Deep01 that rapidly analyzes non-contrast CT brain scans to detect acute intracranial hemorrhages, assisting clinicians in emergency settings.","description":"DeepCT utilizes advanced deep learning algorithms to process non-contrast CT brain images, identifying signs of intracranial hemorrhage (ICH) within 30 seconds and notifying specialists to prioritize and review cases quickly, thereby improving workflow and potentially speeding patient care. It supports, but does not replace, radiologists' diagnostic process. The software has achieved FDA clearance in both the U.S. and Taiwan, and has been implemented in multiple medical institutions, demonstrating its effectiveness in real-world clinical environments.","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","emergency physicians"],"specialties":["Neurology","Emergency Medicine","Radiology"],"regions_available":["United States","Taiwan","Japan","Europe","Southeast Asia","Middle East"],"languages_supported":["English","Chinese","Japanese"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["Taiwan","United States","Japan","Europe","Southeast Asia","Middle East"],"company_founding":"2016","deployment_model":["cloud-based","hybrid","on_prem"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Intracranial hemorrhage (ICH) detection","ICH volume estimation","ICH subtype classification","ICH region classification","ICH score estimation","Marshall score estimation","Evans index estimation","Midline shift estimation","Pneumocephalus detection","Cranial and facial fracture detection","Ischemic stroke detection","Large vessel occlusion (LVO) detection","Aspect score estimation","Automated worklist prioritization","Real-time alerts/notifications","Annotated DICOM outputs (SC, PR)","AI-generated report"],"optional_modules":["Advanced visualization tools","Integration with hospital information systems","Customizable reporting features"],"integrations":["PACS","Stand-alone third-party applications","Stand-alone web-based viewers","Microsoft","NVIDIA","Amazon (AWS)","ASUS","Romion Health"],"data_standards":["DICOM","DICOM Structured Reports (DICOM SR)","DICOM Presentation State (PR)"],"api_available":"unknown","system_requirements":"DICOM-compatible imaging source/PACS; supports cloud deployment, hybrid or local deployment on dedicated hardware (vendor provides appliance or server-side deployment).","compliance":["FDA 510(k) clearance","CE certification (MDD)","Taiwan FDA approval (TFDA)"],"certifications":["FDA 510(k) clearance","CE certification (MDD)","Taiwan FDA approval (TFDA)"],"security_features":["User authentication","Audit logs","Data encryption (in transit and at rest)"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"Supports cloud deployment, hybrid or local deployment on dedicated hardware (vendor provides appliance or server-side deployment).","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0552","slug":"deepct","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/deepct.json"}}