{"product_name":"AudaxCeph","company_name":"Audax","product_url":"https://www.audaxceph.com","company_url":"https://www.audaxceph.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0004","summary":"AudaxCeph is a comprehensive orthodontic software that automates cephalometric analysis, treatment planning, and simulation to enhance orthodontic workflows and patient care.","description":"AudaxCeph is a Class IIa medical device software designed for orthodontic professionals. It automates cephalometric tracing, offers various analysis types, and provides tools for treatment planning, growth projection, and simulation. The software supports both lateral and posteroanterior (PA) cephalometric analyses and integrates patient data management features. AudaxCeph is available in two editions: Essentials and Ultimate, each offering a distinct set of features tailored to different user needs. The software is FDA 510(k) cleared and adheres to ISO 13485 and ISO 9001 standards, ensuring high-quality performance and reliability.","categories":["clinical Care","diagnostic Support","administrative Operations","patient Facing","Clinical","Diagnostic","Administrative","Patient-facing"],"market_segment":["Enterprise","SMB"],"target_users":["Orthodontists","Dental Professionals","Orthodontic Assistants"],"specialties":["Orthodontics"],"regions_available":["United States","Europe","Asia","Australia","Africa","South America","North America","Oceania","Antarctica","Global"],"languages_supported":["English","Slovenian","German","French","Spanish","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Javanese","Turkish","Vietnamese","Telugu"],"pricing_model":"Subscription","pricing_details":"Essentials: €1,650; Ultimate: €3,600; Contact vendor for U.S. pricing and trial information.","license":"Commercial","company_offices":["Slovenia","United States","Germany","France","Italy","Spain","Portugal","Netherlands","Russia","China"],"company_founding":"2015","deployment_model":["on_prem"],"os_platforms":["Windows"],"features":["Automatic cephalometric tracing","Superimposition of analyses and images","Skull growth projection","Visual treatment objectives (VTO & STO)","Image layout management","Treatment simulation videos","Over 200 analysis types","Patient data management","Document organization by treatment stages","Customizable analysis creation"],"optional_modules":["Analysis type creation module","Self-paced training toolkit","Customer help How-To-Videos","Superior technical support","Upgrades","Floating license","No annual fees","Patient and document management","Skull growth projection","Cephalometric visual treatment objective"],"integrations":["Patient Management Software (PMS)"],"data_standards":["XML"],"api_available":"unknown","system_requirements":"Windows OS","compliance":["ISO 9001:2015","ISO 13485:2016","MDR certified","FDA 510(k) cleared"],"certifications":["ISO 9001:2015","ISO 13485:2016","MDR certified","FDA 510(k) cleared"],"security_features":["Data encryption","Role-based access control (RBAC)","Audit logs","Two-factor authentication (2FA)"],"privacy_features":["Data anonymization","Data minimization"],"data_residency":"EU-only","customers":["MiNNOVAA","Oqton","Cyber Medical Imaging, Inc","Axial3D","3D Systems","Cyber Medical Imaging"],"user_reviews":["MiNNOVAA PACS offers a revolutionary radiology solution that promotes seamless collaboration among healthcare professionals, radiologists, and stakeholders.","D2P (DICOM to PRINT) by Oqton provides integrated solutions combining materials, software, 3D printing, and expert services to transform 3D printing."],"ratings":["4.8 out of 5 on G2 for MiNNOVAA PACS","3.5 out of 5 on G2 for D2P (DICOM to PRINT)","3.7 out of 5 on G2 for XDR Dental Imaging Software","4.3 out of 5 on G2 for Axial3D | Medical 3D Printing"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2025","integration_partners":["MiNNOVAA","Oqton","Cyber Medical Imaging, Inc","Axial3D","3D Systems"],"id":"SW0004","slug":"audaxceph","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/audaxceph.json"}}