{"product_name":"RAYDENT SW","company_name":"RAY","product_url":"https://www.ray.co.jp/products/medical/raydent_sw/","company_url":"https://www.ray.co.jp/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0215","summary":"RAYDENT SW is an AI-driven dental software suite that enhances treatment planning and device design through advanced 3D imaging and simulations.","description":"RAYDENT SW is a comprehensive AI-based dental software platform developed by RAY Co., Ltd. It assists dental professionals in planning treatments and designing orthodontic and prosthetic devices by utilizing 3D imaging data and simulations. The suite includes six components: RAYFace Analyzer, RAYFace Designer, Ortho Simulator, Smart Orth, RAYDENT Designer, and SmartCheck, each designed to improve precision and efficiency in dental care. The software has received FDA approval, validating its technology in the global market.","categories":["clinical Care","diagnostic Support","administrative Operations","patient Facing","Clinical","Diagnostic","Administrative","Patient-facing"],"market_segment":["Enterprise","SMB"],"target_users":["Dentists","Orthodontists","Prosthodontists","Dental Technicians"],"specialties":["Orthodontics","Prosthodontics","General Dentistry"],"regions_available":["United States","Japan","South Korea","Europe","Asia"],"languages_supported":["English","Japanese","Korean"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["Japan","United States","South Korea","Germany","China"],"company_founding":"1990","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","Windows","macOS","Linux"],"features":["3D virtual dental model creation","Orthodontic treatment simulation","Design of orthodontic appliances","Prosthesis design (crowns, veneers, bridges)","Treatment planning assistance","Clear aligner design","AI-based CAD for prosthesis creation","Cloud-based simulation and review tools"],"optional_modules":["RAYFace Analyzer","RAYFace Designer","Ortho Simulator","Smart Orth","RAYDENT Designer","SmartCheck"],"integrations":["Compatible dental imaging scanners","Dental imaging software"],"data_standards":["DICOM","HL7 v2","HL7 FHIR","IEEE 11073 SDC"],"api_available":"unknown","system_requirements":["Compatible dental imaging scanners","Dental imaging software"],"compliance":["HIPAA","FDA 21 CFR 11","FDA 21 CFR 820","HITECH","GDPR"],"certifications":["FDA 510(k) clearance (K233625)"],"security_features":["Encryption","Role-based access control","Audit logs","Two-factor authentication","Data loss prevention"],"privacy_features":["Business Associate Agreement (BAA) available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0215","slug":"raydent-sw","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/raydent-sw.json"}}