Soteria.AI

JSON twin: https://www.healthaidb.com/software/soteria-ai.json

Company Name

Omega Medical Imaging

Product URL

https://www.omegamedicalimaging.com/soteria-ai/

Company URL

https://www.omegamedicalimaging.com

Categories

• imaging Software
• cardiology
• radiology
• interventional Procedures
• medical Device
• Clinical Imaging
• Medical Devices

Summary

Soteria.AI is an AI-powered imaging system by Omega Medical Imaging, designed to enhance cardiac care by reducing radiation exposure and improving image quality in interventional procedures.

Description

Soteria.AI integrates FluoroShield™, an AI-driven technology that minimizes X-ray exposure for patients and staff, with advanced imaging capabilities to deliver high-quality, precise diagnostic images. Its compact design and user-friendly features make it suitable for various cardiac catheterization labs, aiming to improve patient safety and procedural efficiency.

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

Company Founding

1990

Company Offices

• United States

Compliance

• HIPAA
• FDA 510(k)
• 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

Customers

Data Residency

US-only

Data Standards

• DICOM
• HL7 v2
• HL7 v3
• FHIR
• SNOMED CT
• ICD-10
• LOINC
• CPT
• ICD-9
• NDC

Deployment Model

• on_prem

Features

• FluoroShield™: AI-powered radiation reduction
• Nyquist.IQ imaging technology
• Responsive CMOS detector
• Enhanced vessel visualization
• Built-in 58-inch HD monitor display
• XY bridge for suspension monitoring
• Customizable boom elevation
• Rotatable C-ARM with telescoping SID
• Programmable C-ARM positions
• Rapid installation within weeks

Id

SW0440

Integration Partners

Integrations

• Epic
• Cerner
• PACS
• Billing Systems

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Chinese
• Japanese
• Korean
• Arabic

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• E-View.AI (Interventional Endoscopy)

Os Platforms

• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• BAA available
• Consent Management
• Anonymization
• Data Minimization
• Data Retention Policy
• Data Access Controls
• Data Encryption
• Data Masking
• Data Segregation
• Data Integrity Checks

Product Code

SW0440

Product Name

Soteria.AI

Ratings

Regions Available

• United States
• Canada
• Europe
• Asia
• Australia

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 Lists

Specialties

• Cardiology
• Interventional Cardiology
• Vascular Imaging
• Diagnostic Imaging

Support Channels

System Requirements

Windows Server 2016 or later, Linux (Ubuntu 18.04 or later), Intel Xeon processor, 16 GB RAM, 1 TB HDD

Target Users

• cardiologists
• radiologists
• medical imaging technicians
• hospital administrators

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Soteria.AI",
  "company_name": "Omega Medical Imaging",
  "product_url": "https://www.omegamedicalimaging.com/soteria-ai/",
  "company_url": "https://www.omegamedicalimaging.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0440",
  "summary": "Soteria.AI is an AI-powered imaging system by Omega Medical Imaging, designed to enhance cardiac care by reducing radiation exposure and improving image quality in interventional procedures.",
  "description": "Soteria.AI integrates FluoroShield™, an AI-driven technology that minimizes X-ray exposure for patients and staff, with advanced imaging capabilities to deliver high-quality, precise diagnostic images. Its compact design and user-friendly features make it suitable for various cardiac catheterization labs, aiming to improve patient safety and procedural efficiency.",
  "categories": [
    "imaging Software",
    "cardiology",
    "radiology",
    "interventional Procedures",
    "medical Device",
    "Clinical Imaging",
    "Cardiology",
    "Radiology",
    "Interventional Procedures",
    "Medical Devices"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "cardiologists",
    "radiologists",
    "medical imaging technicians",
    "hospital administrators"
  ],
  "specialties": [
    "Cardiology",
    "Interventional Cardiology",
    "Vascular Imaging",
    "Diagnostic Imaging"
  ],
  "regions_available": [
    "United States",
    "Canada",
    "Europe",
    "Asia",
    "Australia"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "1990",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "Windows",
    "Linux"
  ],
  "features": [
    "FluoroShield™: AI-powered radiation reduction",
    "Nyquist.IQ imaging technology",
    "Responsive CMOS detector",
    "Enhanced vessel visualization",
    "Built-in 58-inch HD monitor display",
    "XY bridge for suspension monitoring",
    "Customizable boom elevation",
    "Rotatable C-ARM with telescoping SID",
    "Programmable C-ARM positions",
    "Rapid installation within weeks"
  ],
  "optional_modules": [
    "E-View.AI (Interventional Endoscopy)"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS",
    "Billing Systems"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "HL7 v3",
    "FHIR",
    "SNOMED CT",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC"
  ],
  "api_available": "unknown",
  "system_requirements": "Windows Server 2016 or later, Linux (Ubuntu 18.04 or later), Intel Xeon processor, 16 GB RAM, 1 TB HDD",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "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"
  ],
  "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"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit Logs",
    "2FA",
    "DLP",
    "Firewall",
    "Intrusion Detection System",
    "Data Masking",
    "Access Control Lists"
  ],
  "privacy_features": [
    "BAA available",
    "Consent Management",
    "Anonymization",
    "Data Minimization",
    "Data Retention Policy",
    "Data Access Controls",
    "Data Encryption",
    "Data Masking",
    "Data Segregation",
    "Data Integrity Checks"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0440",
  "slug": "soteria-ai",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/soteria-ai.json"
  }
}