LumiNE US

JSON twin: https://www.healthaidb.com/software/lumine-us.json

Company Name

Augmedit

Product URL

https://www.augmedit.com/news/fda-clearance

Company URL

https://www.augmedit.com

Categories

• clinical Care
• diagnostic Support
• surgical Planning
• imaging Software
• augmented Reality
• ai Clinical Documentation Integrity
• clinical Decision Support
• Clinical
• Diagnostic
• Medical Imaging
• Artificial Intelligence

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))

Api Available

unknown

Certifications

• FDA 510(k)

Company Founding

2018

Company Offices

• Netherlands
• United States

Compliance

• FDA 510(k)

Customers

Data Residency

Data stored on-premises

Data Standards

• DICOM

Deployment Model

• on_prem

Features

• 3D Model Creation
• Augmented Reality Visualization
• AI-Based Segmentation
• Surgical Planning Support

Id

SW0163

Integration Partners

Integrations

• Head-Mounted Displays (HMDs)

Languages Supported

• English
• Dutch

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

Os Platforms

• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Data Anonymization
• Consent Management

Product Code

SW0163

Product Name

LumiNE US

Ratings

Regions Available

• United States
• Europe

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Data Encryption
• Access Controls
• Audit Logs

Specialties

• Neurosurgery
• Radiology

Support Channels

System Requirements

Windows 10 or later, macOS 10.15 or later, Linux (Ubuntu 20.04 or later)

Target Users

• Neurosurgeons
• Residents
• Medical Professionals
• Surgeons
• Medical Staff

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "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"
  }
}