{"product_name":"LumiNE US","company_name":"Augmedit","product_url":"https://www.augmedit.com/news/fda-clearance","company_url":"https://www.augmedit.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0163","summary":"LumiNE US is an FDA-cleared software that transforms 2D MRI and CT scans into 3D models, integrating augmented reality and artificial intelligence to enhance surgical planning for neurosurgeons and medical professionals.","description":"LumiNE US is a medical software developed by Augmedit that converts 2D MRI and CT scans into 3D models, integrating augmented reality (AR) and artificial intelligence (AI) to assist in surgical planning. It is intended solely for the preparation phase of surgery, aiding in the visualization of anatomy and pathology for previously diagnosed conditions. The software is tailored for use by neurosurgeons, residents, and other qualified medical professionals within hospital settings. It received FDA clearance on September 10, 2024, for use in surgical planning. ([augmedit.com](https://www.augmedit.com/news/fda-clearance?utm_source=openai))","categories":["clinical Care","diagnostic Support","surgical Planning","imaging Software","augmented Reality","ai Clinical Documentation Integrity","clinical Decision Support","Clinical","Diagnostic","Surgical Planning","Medical Imaging","Augmented Reality","Artificial Intelligence"],"market_segment":["Enterprise","SMB"],"target_users":["Neurosurgeons","Residents","Medical Professionals","Surgeons","Medical Staff"],"specialties":["Neurosurgery","Radiology"],"regions_available":["United States","Europe"],"languages_supported":["English","Dutch"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["Netherlands","United States"],"company_founding":"2018","deployment_model":["on_prem"],"os_platforms":["Windows","macOS","Linux"],"features":["3D Model Creation","Augmented Reality Visualization","AI-Based Segmentation","Surgical Planning Support"],"optional_modules":[],"integrations":["Head-Mounted Displays (HMDs)"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"Windows 10 or later, macOS 10.15 or later, Linux (Ubuntu 20.04 or later)","compliance":["FDA 510(k)"],"certifications":["FDA 510(k)"],"security_features":["Data Encryption","Access Controls","Audit Logs"],"privacy_features":["Data Anonymization","Consent Management"],"data_residency":"Data stored on-premises","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0163","slug":"lumine-us","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/lumine-us.json"}}