{"product_name":"Viz SDH","company_name":"Viz.ai","product_url":"https://www.viz.ai/hemorrhage","company_url":"https://www.viz.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0415","summary":"Viz SDH is an AI-powered software by Viz.ai that automatically detects and quantifies subdural hemorrhages in non-contrast CT scans, aiding clinicians in rapid and accurate treatment decisions.","description":"Viz SDH utilizes artificial intelligence to identify acute and chronic subdural hemorrhages in non-contrast CT images, providing automated notifications and precise measurements to support timely clinical interventions.","categories":["clinical Care","diagnostic Support","neurology","Clinical","Diagnostic","Neurovascular"],"market_segment":["enterprise","smb"],"target_users":["clinicians","neurosurgeons","radiologists","emergency physicians"],"specialties":["Neurology","Neurosurgery","Radiology","Emergency Medicine"],"regions_available":["United States","Europe"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States","Europe"],"company_founding":"2016","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android"],"features":["Automated detection of suspected acute and chronic subdural hematomas (SDH)","Real-time SDH detection and quantification","Consistent, accurate measurements available on desktop and mobile devices","Automated notifications and real-time alerts","Mobile and desktop review (physician mobile app)","Labeling and visualization on CT","Triage and care-team coordination/workflow orchestration","Interhospital transfer coordination support","Case escalation and messaging","Audit logging and event history","Measurement reporting and export","Integration with PACS/RIS for image ingestion","Clinical decision support for neurovascular workflows"],"optional_modules":["Viz ICH","Viz ICH Plus","Viz LVO","Viz Vascular Suite","Viz Cardio Suite","Viz Trauma Suite","Viz Radiology Suite"],"integrations":["Epic","Cerner","PACS","RIS","Hospital EHRs","DICOM modalities","Microsoft Cloud for Healthcare","Email/SMS/secure messaging for notifications","Single sign-on providers (SAML/IdP integration)"],"data_standards":["DICOM","HL7 v2","FHIR","SNOMED CT","ICD-10"],"api_available":"yes","system_requirements":"DICOM-enabled CT/PACS connectivity; hospital network access; modern web browser for desktop; iOS/Android mobile app; cloud connectivity (or on-prem server for hybrid deployments)","compliance":["HIPAA","HITECH","GDPR","SOC 2","ISO 27001","ISO 27032","ISO 27017","ISO 27018","ISO 27701","ISO 27799"],"certifications":["FDA 510(k) clearance (Viz ICH / Viz ICH Plus)","FDA De Novo clearance (Viz LVO DEN170073)","CE Marking (MDD Class I)"],"security_features":["Encryption in transit and at rest","Role-based access control (RBAC)","SSO/SAML","Audit logs","Two-factor authentication (2FA)"],"privacy_features":["Business Associate Agreement (BAA) available","HIPAA-compliant handling","Data minimization/anonymization options"],"data_residency":"US and EU cloud region options; on-prem hosting available for local residency","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0415","slug":"viz-sdh","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/viz-sdh.json"}}