FLASH Navigation

JSON twin: https://www.healthaidb.com/software/flash-navigation.json

Company Name

7D Surgical

Product URL

https://7dsurgical.com/flash-navigation/

Company URL

https://7dsurgical.com

Categories

• clinical Care
• diagnostic Support
• surgical Navigation
• imaging Software
• surgical Care
• Clinical
• Diagnostic
• Radiation-free Imaging
• Machine-vision Technology
• Spine Surgery
• Cranial Surgery
• Minimally Invasive Surgery
• Orthopedic Surgery
• Neurosurgery

Summary

FLASH Navigation by 7D Surgical is a machine-vision-based system that enables rapid, radiation-free 3D image-guided navigation for spine and cranial surgeries, enhancing surgical efficiency and accuracy.

Description

FLASH Navigation utilizes proprietary machine-vision technology to provide near-instantaneous 3D registration in under 30 seconds, eliminating the need for intraoperative CT scans and fluoroscopy. This system offers real-time navigation with high accuracy, regardless of patient positioning or intraoperative movement, and is designed to integrate seamlessly into existing surgical workflows without disrupting procedures. It is available in percutaneous, spine, and cranial modules, catering to various surgical needs. The system is compatible with multiple 3D intraoperative imaging systems and is open-platform, allowing navigation of other implant systems without disrupting surgical techniques. Additionally, FLASH Navigation is designed to be portable and has a small footprint, making it suitable for various operating room environments. The system has been adopted in multiple countries, including the United States, Canada, Singapore, Australia, New Zealand, and European nations such as Germany and Switzerland. It supports multiple languages, including English and Italian, and is available through a subscription pricing model. The company, 7D Surgical, was founded in 2017 and has offices in Canada and the United States.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• 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

Company Founding

2017

Company Offices

• Canada
• United States
• Germany
• Switzerland
• United Kingdom
• France
• Italy
• Spain
• Australia
• New Zealand

Compliance

• HIPAA
• FDA 510(k)
• ISO 13485
• CE Mark
• 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

Customers

Data Residency

US/EU regions

Data Standards

• DICOM
• HL7
• FHIR

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Machine-Vision Technology
• Instant FLASH™ Registration
• Radiation-Free Navigation
• Segmental Registration
• Sterile System Control
• Real-Time Implant Sizing
• Foot Pedal Control
• On-Board Surgical Light Integration
• 3D Optical Technologies
• Fast 3D Image Reconstruction

Id

SW0107

Integration Partners

Integrations

• Orthofix Surgical Navigation System
• SeaSpine FLASH Navigation System
• CDA Spine FLASH Navigation System
• Orthofix 7D FLASH Navigation System Percutaneous Module 2.0

Languages Supported

• English
• Italian
• German
• French
• Spanish
• Portuguese
• Dutch
• Swedish
• Norwegian
• Danish

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Percutaneous Module 2.0
• Cranial Module
• Spine Module

Os Platforms

• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• BAA available
• Consent Management
• Anonymization
• Data Minimization

Product Code

SW0107

Product Name

FLASH Navigation

Ratings

Regions Available

• United States
• Canada
• Singapore
• Australia
• New Zealand
• Germany
• Switzerland
• European Union
• United Kingdom
• France

Related Urls

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

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit Logs
• 2FA
• DLP

Specialties

• Spine Surgery
• Cranial Surgery
• Orthopedic Surgery
• Neurosurgery
• Minimally Invasive Surgery

Support Channels

System Requirements

• Intel Core i7 processor
• 16 GB RAM
• NVIDIA GTX 1080 GPU
• Windows 10 Pro
• Linux Ubuntu 20.04 LTS

Target Users

• Surgeons
• Orthopedic Surgeons
• Neurosurgeons
• Operating Room Staff
• Hospital Administrators

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "FLASH Navigation",
  "company_name": "7D Surgical",
  "product_url": "https://7dsurgical.com/flash-navigation/",
  "company_url": "https://7dsurgical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0107",
  "summary": "FLASH Navigation by 7D Surgical is a machine-vision-based system that enables rapid, radiation-free 3D image-guided navigation for spine and cranial surgeries, enhancing surgical efficiency and accuracy.",
  "description": "FLASH Navigation utilizes proprietary machine-vision technology to provide near-instantaneous 3D registration in under 30 seconds, eliminating the need for intraoperative CT scans and fluoroscopy. This system offers real-time navigation with high accuracy, regardless of patient positioning or intraoperative movement, and is designed to integrate seamlessly into existing surgical workflows without disrupting procedures. It is available in percutaneous, spine, and cranial modules, catering to various surgical needs. The system is compatible with multiple 3D intraoperative imaging systems and is open-platform, allowing navigation of other implant systems without disrupting surgical techniques. Additionally, FLASH Navigation is designed to be portable and has a small footprint, making it suitable for various operating room environments. The system has been adopted in multiple countries, including the United States, Canada, Singapore, Australia, New Zealand, and European nations such as Germany and Switzerland. It supports multiple languages, including English and Italian, and is available through a subscription pricing model. The company, 7D Surgical, was founded in 2017 and has offices in Canada and the United States.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "surgical Navigation",
    "imaging Software",
    "surgical Care",
    "Clinical",
    "Diagnostic",
    "Surgical Navigation",
    "Radiation-free Imaging",
    "Machine-vision Technology",
    "Spine Surgery",
    "Cranial Surgery",
    "Minimally Invasive Surgery",
    "Orthopedic Surgery",
    "Neurosurgery"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Surgeons",
    "Orthopedic Surgeons",
    "Neurosurgeons",
    "Operating Room Staff",
    "Hospital Administrators"
  ],
  "specialties": [
    "Spine Surgery",
    "Cranial Surgery",
    "Orthopedic Surgery",
    "Neurosurgery",
    "Minimally Invasive Surgery"
  ],
  "regions_available": [
    "United States",
    "Canada",
    "Singapore",
    "Australia",
    "New Zealand",
    "Germany",
    "Switzerland",
    "European Union",
    "United Kingdom",
    "France"
  ],
  "languages_supported": [
    "English",
    "Italian",
    "German",
    "French",
    "Spanish",
    "Portuguese",
    "Dutch",
    "Swedish",
    "Norwegian",
    "Danish"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "Canada",
    "United States",
    "Germany",
    "Switzerland",
    "United Kingdom",
    "France",
    "Italy",
    "Spain",
    "Australia",
    "New Zealand"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Windows",
    "Linux"
  ],
  "features": [
    "Machine-Vision Technology",
    "Instant FLASH™ Registration",
    "Radiation-Free Navigation",
    "Segmental Registration",
    "Sterile System Control",
    "Real-Time Implant Sizing",
    "Foot Pedal Control",
    "On-Board Surgical Light Integration",
    "3D Optical Technologies",
    "Fast 3D Image Reconstruction"
  ],
  "optional_modules": [
    "Percutaneous Module 2.0",
    "Cranial Module",
    "Spine Module"
  ],
  "integrations": [
    "Orthofix Surgical Navigation System",
    "SeaSpine FLASH Navigation System",
    "CDA Spine FLASH Navigation System",
    "Orthofix 7D FLASH Navigation System Percutaneous Module 2.0"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR"
  ],
  "api_available": "unknown",
  "system_requirements": [
    "Intel Core i7 processor",
    "16 GB RAM",
    "NVIDIA GTX 1080 GPU",
    "Windows 10 Pro",
    "Linux Ubuntu 20.04 LTS"
  ],
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 13485",
    "CE Mark",
    "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",
    "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": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit Logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent Management",
    "Anonymization",
    "Data Minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0107",
  "slug": "flash-navigation",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/flash-navigation.json"
  }
}