{"product_name":"X-Guide","company_name":"X-Nav Technologies","product_url":"https://x-navtech.com/x-guide/","company_url":"https://x-navtech.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0253","summary":"X-Guide is a dynamic 3D surgical navigation system developed by X-Nav Technologies, designed to enhance precision and control in dental implant procedures, facilitating more accurate and less invasive surgeries.","description":"X-Guide provides real-time, interactive guidance during dental implant surgeries, allowing clinicians to visualize precise movements of the surgical handpiece, thereby improving implant position, angle, and depth. It integrates seamlessly with cone beam 3D imaging systems and offers features like X-Point technology for single-view guidance of implant parameters. The system has received FDA clearance and EU MDR certification, underscoring its safety and efficacy in dental surgical applications.","categories":["clinical Care","diagnostic Support","surgical Navigation","surgical Care","Clinical","Diagnostic","Surgical Navigation","Dental Implantology"],"market_segment":["Enterprise","SMB"],"target_users":["Dentists","Oral Surgeons","Dental Implant Specialists"],"specialties":["Oral Surgery","Periodontics","Prosthodontics"],"regions_available":["United States","European Union","Canada","Australia","Japan","South Korea","Brazil","Mexico","India","China","South Africa","Russia","Argentina","Chile","Colombia","Peru","Venezuela","Egypt","Saudi Arabia","United Arab Emirates"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Germany","United Kingdom","France","Italy","Spain","Canada","Australia","Japan","South Korea"],"company_founding":"2012","deployment_model":["on_prem"],"os_platforms":["Windows","macOS","Linux"],"features":["Dynamic 3D surgical navigation","Real-time implant guidance","X-Point™ navigation technology","X-Mark™ virtual-based registration","X-Guide NXT integration","IconiX AI integration","FastMap photogrammetry","Endodontic access procedures","Full-arch reconstruction support","Minimally invasive implant placement","Same-day guided surgery","Digital treatment planning","Cone beam 3D imaging compatibility","Live surgical courses","Clinical education programs","Software updates and support","International language support","Regulatory compliance","Patent portfolio","University collaborations"],"optional_modules":["X-Guide NXT","IconiX AI","FastMap photogrammetry","X-Mark virtual-based registration"],"integrations":["Cone beam 3D scanners","X-Guide NXT","IconiX AI","FastMap photogrammetry","X-Mark virtual-based registration","DTX Studio","Sprintray 3D printing"],"data_standards":["DICOM","HL7","SNOMED","ICD-10","LOINC","CPT","ICD-9","HCPCS","NDC","RxNorm"],"api_available":"no","system_requirements":"Windows 10 or later, macOS 10.15 or later, Linux (Ubuntu 20.04 LTS or later)","compliance":["FDA 510(k)","EU MDR","ISO 13485","ISO 14971","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12"],"certifications":["FDA 510(k)","EU MDR","ISO 13485","ISO 14971","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12"],"security_features":["Data encryption","Role-based access control (RBAC)","Audit logs","Secure data storage","User authentication","Data integrity checks","Secure communication protocols","Regular security updates","Compliance with security standards","Incident response plan"],"privacy_features":["Data anonymization","Data minimization","User consent management","Data access controls","Data retention policies","Compliance with privacy regulations","Patient data confidentiality","Secure data transmission","Data backup and recovery","Third-party data sharing controls"],"data_residency":"US and EU data centers","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0253","slug":"x-guide","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/x-guide.json"}}