{"product_name":"7D Surgical System","company_name":"TransEnterix","product_url":"https://www.transenterix.com/7d-surgical-system","company_url":"https://www.transenterix.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0530","summary":"The 7D FLASH™ Navigation System is an image-guided surgical platform that enhances precision and efficiency in spine and cranial procedures by utilizing machine-vision technology for rapid, radiation-free 3D imaging.","description":"The 7D FLASH™ Navigation System offers advanced image-guided navigation for spine and cranial surgeries, providing rapid, radiation-free 3D imaging through machine-vision technology. It features near-instant 3D registration, optimized workflow integration, high accuracy with real-time navigation, and cost-effective operation by eliminating the need for intraoperative radiology equipment. The system is designed for use in both open and minimally invasive procedures, enhancing surgical precision and efficiency.","categories":["clinical Care","diagnostic Support","surgical Navigation","surgical Care","Clinical","Diagnostic","Surgical Navigation","Spine Surgery","Cranial Surgery"],"market_segment":["Enterprise","SMB"],"target_users":["Surgeons","Operating Room Staff","Hospital Administrators"],"specialties":["Spine Surgery","Cranial Surgery"],"regions_available":["United States","European Union","Japan","Other Select Countries"],"languages_supported":["English","Other Languages as Supported by Regional Markets"],"pricing_model":"Enterprise_Quote","pricing_details":"Contact Vendor for Pricing Information","license":"Commercial","company_offices":["United States","European Union","Japan","Other Select Countries"],"company_founding":"2017","deployment_model":["on_prem"],"os_platforms":["Windows","Linux"],"features":["Robotic-assisted surgery","Laparoscopic instrument control","Digital laparoscopy","Augmented intelligence","Machine vision integration","Reusable instruments","Advanced energy tools","Ultrasonic system integration","Intelligent Surgical Unit (ISU)","FDA 510(k) clearance","CE Mark approval","Surgical visualization enhancement","Endoscopic tissue manipulation","Surgical field visualization","Instrument tracking","Surgical image analytics","Scene cognition","Surgical data analytics","Clinical workflow optimization","Surgical precision enhancement"],"optional_modules":["Intelligent Surgical Unit (ISU)","Advanced energy tools","Ultrasonic system integration","Machine vision integration","Augmented intelligence features","Surgical image analytics","Scene cognition","Surgical data analytics","Clinical workflow optimization","Surgical precision enhancement"],"integrations":["Intelligent Surgical Unit (ISU)","Advanced energy tools","Ultrasonic system integration","Machine vision integration","Augmented intelligence features","Surgical image analytics","Scene cognition","Surgical data analytics","Clinical workflow optimization","Surgical precision enhancement"],"data_standards":["HL7","DICOM","FHIR","SNOMED","ICD-10","LOINC","CPT","ICD-9","NDC","HCPCS"],"api_available":"unknown","system_requirements":"Windows Server 2016 or later, Linux kernel 4.4 or later, 16 GB RAM, 500 GB SSD storage, 1 Gbps Ethernet connection","compliance":["HIPAA","FDA 510(k)","CE Mark","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","IEC 60601-1-15","IEC 60601-1-16","IEC 60601-1-17","IEC 60601-1-18","IEC 60601-1-19","IEC 60601-1-20","IEC 60601-1-21","IEC 60601-1-22","IEC 60601-1-23","IEC 60601-1-24"],"certifications":["FDA 510(k)","CE Mark","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","IEC 60601-1-15","IEC 60601-1-16","IEC 60601-1-17","IEC 60601-1-18","IEC 60601-1-19","IEC 60601-1-20","IEC 60601-1-21","IEC 60601-1-22","IEC 60601-1-23","IEC 60601-1-24"],"security_features":["Data encryption","Role-based access control (RBAC)","Single sign-on (SSO)","Audit logs","Two-factor authentication (2FA)","Data loss prevention (DLP)","Network segmentation","Secure API communications","Compliance with security standards","Advanced security controls"],"privacy_features":["Business Associate Agreement (BAA)","Consent management","Data anonymization","Data minimization","Compliance with privacy regulations","Patient data protection","Confidentiality agreements","Data access controls","Data retention policies","Data sharing policies"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0530","slug":"7d-surgical-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/7d-surgical-system.json"}}