TOMTEC-ARENA

JSON twin: https://www.healthaidb.com/software/tomtec-arena.json

Company Name

TOMTEC Imaging Systems

Product URL

https://www.tomtec.de/products/tomtec-arena/

Company URL

https://www.tomtec.de

Categories

• clinical Care
• diagnostic Support
• imaging Software
• health Data Analytics
• clinical Workflow Automation
• Clinical
• Diagnostic
• Image Analysis
• Reporting
• Workflow Integration

Summary

TOMTEC-ARENA is a comprehensive cardiovascular imaging solution offering automated analysis and reporting across multiple modalities, enhancing diagnostic confidence and workflow efficiency.

Description

TOMTEC-ARENA is a suite of clinical applications designed to review, analyze, and quantify medical image data in multiple dimensions (2D, 3D, and 4D) and modalities, including ultrasound, angiography, magnetic resonance (MR), and nuclear medicine. It integrates automated solutions for 2D and 3D volume measurements and strain imaging, providing highly reproducible and reliable results to support clinical decision-making processes. The software is available as a standalone workstation or network configuration and can be integrated into existing hospital IT infrastructures without adding complexity for the IT department. It is also available as an integrated version within many picture archiving and communication systems (PACS) and electronic medical record (EMR) systems on the market without the need for a separate server. ([itnonline.com](https://www.itnonline.com/content/tomtec-receives-fda-510k-clearance-tomtec-arena-software?utm_source=openai))

Api Available

yes

Certifications

• FDA 510(k)
• CE Marking
• ISO 13485
• ISO 9001
• IEC 62304
• IEC 62366
• 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

1990

Company Offices

• Germany
• United States
• France
• United Kingdom
• Italy
• Spain
• Netherlands
• Switzerland
• China
• Japan

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• ISO 13485
• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• IEC 62304
• IEC 62366
• 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

Customers

Data Residency

EU-only, US/EU regions, BYO cloud region

Data Standards

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

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated clinical tools for cardiovascular imaging
• Vendor-neutral, multi-modality capabilities
• Integrated clinical practice and advanced analysis tools
• Image management solutions
• Comprehensive image review and measurement
• 3D/4D multiplanar reconstruction
• Side-by-side comparison of current and prior studies
• Measurement modules for echocardiography, vascular, and X-ray angiography
• Automated measurement value import
• XA viewer with biplane imaging support
• Smart link between measurement and image
• Measurement export in different formats
• Cardiovascular measurement packages for 2D echo, M-Mode, and Doppler studies
• Control for completeness of measurement data
• Stress echo analysis
• AutoLV for biplane left ventricular volume quantification
• AutoLA for biplane left atrial volume quantification
• AutoIMT for intima-media thickness analysis
• 2D Strain for global and regional assessment of myocardial mechanics

Id

SW0435

Integration Partners

Integrations

• PACS
• CVIS
• EMR
• ECG
• IVUS
• IVOCT/OCT
• NM
• Stress Echo Systems
• 3D Echo Data Sources
• Measurement Devices
• Reporting Systems
• Research Databases
• Clinical Decision Support Systems
• Hospital Information Systems
• Laboratory Information Systems
• Patient Monitoring Systems
• Imaging Modalities
• Data Repositories
• Clinical Trial Management Systems
• Medical Device Interfaces

Languages Supported

• English
• German
• French
• Spanish
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Turkish
• Polish
• Swedish
• Norwegian
• Danish
• Finnish
• Greek

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• 4D LV-ANALYSIS for 3D quantification of left ventricular volume and function
• 4D RV-FUNCTION for quantification of right ventricular volumes, function, and strain
• 4D CARDIO-VIEW for generic three-dimensional software solution
• 4D MV-ASSESSMENT for comprehensive assessment and quantification of mitral valve anatomy and function
• AutoSTRAIN for quantification of global and regional function, including longitudinal strain
• 4D SONO-SCAN for comprehensive review and analysis of multi-vendor 4D radiological ultrasound data
• 4D Cardio-View for vendor-independent offline solution to review and analyze 3D echo data
• Measurement Mapping Service for standardizing diverse DICOM SR formats into a defined DICOM format

Os Platforms

• Web
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• Consent Management
• Anonymization
• Data Minimization
• Data Retention Policy
• Data Access Control
• Data Encryption
• Data Masking
• Data Segregation
• Data Deletion Policy

Product Code

SW0435

Product Name

TOMTEC-ARENA

Ratings

Regions Available

• United States
• Germany
• Europe
• Asia
• Australia
• Canada
• South America
• Africa
• Middle East
• India

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
• Firewall
• Intrusion Detection System
• Data Masking
• Access Control

Specialties

• Cardiology
• Radiology
• Vascular Imaging
• Nuclear Medicine
• Magnetic Resonance Imaging

Support Channels

System Requirements

Windows Server, Linux Server, macOS Server, Intel Xeon Processor, 16 GB RAM, 500 GB HDD, 1 Gbps Network

Target Users

• clinicians
• radiologists
• cardiologists
• medical imaging professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "TOMTEC-ARENA",
  "company_name": "TOMTEC Imaging Systems",
  "product_url": "https://www.tomtec.de/products/tomtec-arena/",
  "company_url": "https://www.tomtec.de",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0435",
  "summary": "TOMTEC-ARENA is a comprehensive cardiovascular imaging solution offering automated analysis and reporting across multiple modalities, enhancing diagnostic confidence and workflow efficiency.",
  "description": "TOMTEC-ARENA is a suite of clinical applications designed to review, analyze, and quantify medical image data in multiple dimensions (2D, 3D, and 4D) and modalities, including ultrasound, angiography, magnetic resonance (MR), and nuclear medicine. It integrates automated solutions for 2D and 3D volume measurements and strain imaging, providing highly reproducible and reliable results to support clinical decision-making processes. The software is available as a standalone workstation or network configuration and can be integrated into existing hospital IT infrastructures without adding complexity for the IT department. It is also available as an integrated version within many picture archiving and communication systems (PACS) and electronic medical record (EMR) systems on the market without the need for a separate server. ([itnonline.com](https://www.itnonline.com/content/tomtec-receives-fda-510k-clearance-tomtec-arena-software?utm_source=openai))",
  "categories": [
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    "Reporting",
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  "target_users": [
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  "specialties": [
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    "Radiology",
    "Vascular Imaging",
    "Nuclear Medicine",
    "Magnetic Resonance Imaging"
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  "regions_available": [
    "United States",
    "Germany",
    "Europe",
    "Asia",
    "Australia",
    "Canada",
    "South America",
    "Africa",
    "Middle East",
    "India"
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  "languages_supported": [
    "English",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Turkish",
    "Polish",
    "Swedish",
    "Norwegian",
    "Danish",
    "Finnish",
    "Greek"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "Germany",
    "United States",
    "France",
    "United Kingdom",
    "Italy",
    "Spain",
    "Netherlands",
    "Switzerland",
    "China",
    "Japan"
  ],
  "company_founding": "1990",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Automated clinical tools for cardiovascular imaging",
    "Vendor-neutral, multi-modality capabilities",
    "Integrated clinical practice and advanced analysis tools",
    "Image management solutions",
    "Comprehensive image review and measurement",
    "3D/4D multiplanar reconstruction",
    "Side-by-side comparison of current and prior studies",
    "Measurement modules for echocardiography, vascular, and X-ray angiography",
    "Automated measurement value import",
    "XA viewer with biplane imaging support",
    "Smart link between measurement and image",
    "Measurement export in different formats",
    "Cardiovascular measurement packages for 2D echo, M-Mode, and Doppler studies",
    "Control for completeness of measurement data",
    "Stress echo analysis",
    "AutoLV for biplane left ventricular volume quantification",
    "AutoLA for biplane left atrial volume quantification",
    "AutoIMT for intima-media thickness analysis",
    "2D Strain for global and regional assessment of myocardial mechanics"
  ],
  "optional_modules": [
    "4D LV-ANALYSIS for 3D quantification of left ventricular volume and function",
    "4D RV-FUNCTION for quantification of right ventricular volumes, function, and strain",
    "4D CARDIO-VIEW for generic three-dimensional software solution",
    "4D MV-ASSESSMENT for comprehensive assessment and quantification of mitral valve anatomy and function",
    "AutoSTRAIN for quantification of global and regional function, including longitudinal strain",
    "4D SONO-SCAN for comprehensive review and analysis of multi-vendor 4D radiological ultrasound data",
    "4D Cardio-View for vendor-independent offline solution to review and analyze 3D echo data",
    "Measurement Mapping Service for standardizing diverse DICOM SR formats into a defined DICOM format"
  ],
  "integrations": [
    "PACS",
    "CVIS",
    "EMR",
    "ECG",
    "IVUS",
    "IVOCT/OCT",
    "NM",
    "Stress Echo Systems",
    "3D Echo Data Sources",
    "Measurement Devices",
    "Reporting Systems",
    "Research Databases",
    "Clinical Decision Support Systems",
    "Hospital Information Systems",
    "Laboratory Information Systems",
    "Patient Monitoring Systems",
    "Imaging Modalities",
    "Data Repositories",
    "Clinical Trial Management Systems",
    "Medical Device Interfaces"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC",
    "HCPCS"
  ],
  "api_available": "yes",
  "system_requirements": "Windows Server, Linux Server, macOS Server, Intel Xeon Processor, 16 GB RAM, 500 GB HDD, 1 Gbps Network",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "ISO 13485",
    "FDA 21 CFR Part 820",
    "FDA 21 CFR Part 11",
    "IEC 62304",
    "IEC 62366",
    "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"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Marking",
    "ISO 13485",
    "ISO 9001",
    "IEC 62304",
    "IEC 62366",
    "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",
    "Firewall",
    "Intrusion Detection System",
    "Data Masking",
    "Access Control"
  ],
  "privacy_features": [
    "BAA available",
    "Consent Management",
    "Anonymization",
    "Data Minimization",
    "Data Retention Policy",
    "Data Access Control",
    "Data Encryption",
    "Data Masking",
    "Data Segregation",
    "Data Deletion Policy"
  ],
  "data_residency": "EU-only, US/EU regions, BYO cloud region",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0435",
  "slug": "tomtec-arena",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
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  }
}