7D Surgical System

JSON twin: https://www.healthaidb.com/software/7d-surgical-system.json

Company Name

TransEnterix

Product URL

https://www.transenterix.com/7d-surgical-system

Company URL

https://www.transenterix.com

Categories

• clinical Care
• diagnostic Support
• surgical Navigation
• surgical Care
• Clinical
• Diagnostic
• Spine Surgery
• Cranial Surgery

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.

Api Available

unknown

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

Company Founding

2017

Company Offices

• United States
• European Union
• Japan
• Other Select Countries

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

Customers

Data Residency

US-only

Data Standards

• HL7
• DICOM
• FHIR
• SNOMED
• ICD-10
• LOINC
• CPT
• ICD-9
• NDC
• HCPCS

Deployment Model

• on_prem

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

Id

SW0530

Integration Partners

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

Languages Supported

• English
• Other Languages as Supported by Regional Markets

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

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

Os Platforms

• Windows
• Linux

Pricing Details

Contact Vendor for Pricing Information

Pricing Model

Enterprise_Quote

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

Product Code

SW0530

Product Name

7D Surgical System

Ratings

Regions Available

• United States
• European Union
• Japan
• Other Select Countries

Related Urls

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

Release Year

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

Specialties

• Spine Surgery
• Cranial Surgery

Support Channels

System Requirements

Windows Server 2016 or later, Linux kernel 4.4 or later, 16 GB RAM, 500 GB SSD storage, 1 Gbps Ethernet connection

Target Users

• Surgeons
• Operating Room Staff
• Hospital Administrators

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "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"
  }
}