{"product_name":"Rapid SDH","company_name":"RapidAI","product_url":"https://www.rapidai.com/rapid-sdh","company_url":"https://www.rapidai.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0298","summary":"Rapid SDH is an AI-powered software developed by iSchemaView to assist radiologists in detecting and triaging suspected hemispheric subdural hemorrhages (SDH) in non-contrast head CT scans, enhancing workflow efficiency and patient care.","description":"Rapid SDH is an AI-based software that analyzes non-contrast head CT images to detect suspected hemispheric subdural hemorrhages (SDH). It operates in parallel with standard readings, providing timely notifications with preview images to assist clinicians in workflow management and improve patient care. The software has demonstrated a sensitivity of 93% and specificity of 99% for detecting acute and chronic hemispheric SDH greater than 1 mL, with a median processing time of 45 seconds. It automatically sends notifications through the Rapid mobile app, PACS, and email, facilitating treatment and transfer decisions for patients with subdural hematomas. Rapid SDH received FDA clearance on October 25, 2023. ([xrayinterpreter.com](https://xrayinterpreter.com/fda/K232436?utm_source=openai))","categories":["clinical Care","diagnostic Support","radiology","imaging Software","clinical Workflow Optimization","care Coordination","Clinical","Diagnostic","Radiology","Neuroimaging","Ai-powered Imaging","Workflow Optimization","Patient Care Enhancement"],"market_segment":["enterprise","smb"],"target_users":["radiologists","neurocritical care teams","emergency department physicians","trauma surgeons","neurologists"],"specialties":["Neurology","Neurosurgery","Emergency Medicine","Radiology"],"regions_available":["United States","Europe","Asia","Australia","Canada","South America","Africa","Middle East"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Urdu","Turkish","Vietnamese","Thai","Polish"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Germany","India","China","Japan","South Korea","Brazil","United Kingdom","France","Australia"],"company_founding":"2010","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android"],"features":["AI-driven hemorrhage detection","Quantification of hyperdense tissue","Rapid assessment for acute hemorrhages","Integration with hospital PACS systems","Real-time notifications for care teams","Customizable notification settings","Secure communication channels within app","Support for multiple imaging modalities","FDA-cleared for thrombectomy decision support"],"optional_modules":["Advanced analytics","Clinical decision support tools"],"integrations":["PACS systems","Hospital EMR/EHR systems","Third-party communication apps"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":"Web browser, iOS or Android device","compliance":["HIPAA","GDPR","ISO 27001","ISO 13485"],"certifications":["FDA 510(k) clearance","CE Marking","ISO 13485","ISO 27001"],"security_features":["Encryption","Role-based access control (RBAC)","Audit logs","Single sign-on (SSO)","Secure cloud storage options"],"privacy_features":["Business Associate Agreement (BAA) available","Data minimization via archiving","Ability to keep/offload copies offsite"],"data_residency":"US and EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0298","slug":"rapid-sdh","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/rapid-sdh.json"}}