Soteria.AI

by Omega Medical Imaging  · Based in United States → — The First Ever FDA-Approved AI-Enabled X-Ray System for Cardiology, Redefining Interventional Imaging for Cardiologists.
Cardiology Interventional Radiology Radiology
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Regulatory Status Disclosed

Overview

Soteria.AI by Omega Medical Imaging is a revolutionary AI image-guided interventional X-ray system engineered specifically for cardiac catheterization labs. It represents a significant advancement in precision and safety within interventional imaging. At its core is FluoroShield™, an AI-powered radiation reduction technology that has demonstrated the ability to reduce radiation exposure for both patients and staff by up to ~84%.

The system features a patented telescoping SID and groundbreaking 5th axis movement, ensuring optimal patient access and angulations within a space-efficient footprint. It incorporates a highly responsive CMOS detector and Nyquist Image Processor to deliver unparalleled image quality for precise diagnosis and treatment, enhancing vessel visualization. Soteria.AI’s AI capabilities include automatic Region of Interest (ROI) detection and collimation, which provides consistent and repeatable radiation reduction beyond what conventional systems can offer, without interrupting workflow.

Designed for reliability and safety, Soteria.AI includes built-in radiation safety controls and operator-programmable presets for C-arm and table positioning. It is compatible with DICOM for seamless integration into existing medical imaging workflows.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI Image-Guided Interventional System
  • FluoroShieldu2122 AI-powered radiation reduction (up to ~84%)
  • Patented telescoping SID and 5th axis movement
  • Nyquist Image Processor for superior image quality
  • Responsive CMOS detector for enhanced visualization
  • AI-enabled automatic Region of Interest (ROI) collimation
  • Built-in radiation safety controls
  • DICOM compatibility for image exchange
  • Operator programmable presets for C-arm and table position

Use Cases

  • Cardiac catheterization labs
  • Interventional cardiology procedures
  • Vascular imaging
  • General radiographic/fluoroscopic diagnostic imaging
  • Interventional X-ray imaging for General and Pediatric Populations
  • Interventional endoscopy (with related E-View.AI system)

What Physicians Need to Know

Interventional Imaging Focus
Soteria.AI is an AI-enabled X-ray system specifically designed for image-guided interventional cardiology procedures in the cardiac catheterization lab.
Radiation Reduction
The system features AI image-guided Region of Interest (ROI) technology, including FluoroShieldu2122, which is proven to reduce radiation exposure for patients and staff by up to 84%.
Advanced Image Quality & Visualization
Soteria.AI delivers unrivaled image quality with Nyquist.IQ and a highly responsive CMOS detector, ensuring advanced feature detectability and enhanced visualization of vessels and catheters during procedures.
Coronary Artery Assessment Support
While not a diagnostic tool, the system's advanced detection and visualization capabilities directly support interventional cardiologists in assessing and navigating coronary arteries and catheters in real-time during procedures.
Real-Time Insights & Controls
The system provides real-time insights and intuitive controls to enhance the cardiac care experience during interventional procedures.
Optimized Patient Access & Angulations
Its patented telescoping SID and groundbreaking 5th axis movement ensure optimal patient access and angulations within a space-efficient footprint, delivering projections similar to larger ceiling-mounted systems.
FDA Approval
Soteria.AI is an FDA-approved AI-enabled X-ray system for cardiology.
Physician Tip

Leverage Soteria.AI's AI-guided radiation reduction capabilities to significantly minimize dose for both patients and staff during complex interventional procedures. Utilize the system's superior image quality and enhanced visualization of vessels and catheters for precise navigation and real-time decision-making in the cardiac catheterization lab. The flexible C-arm design and advanced positioning features can improve patient access and procedural efficiency.

Soteria.AI is designed as a comprehensive image-guided X-ray system for seamless integration into existing cardiac catheterization lab workflows. Its primary integration points are within the interventional suite, complementing other cath lab equipment and facilitating efficient image archiving via DICOM compatibility.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentOn-premise hardware system (installed in medical facilities)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Soteria.AI system (Model AI-100) received FDA 510(k) clearance (K212336) on November 17, 2021. It is classified as an interventional fluoroscopic X-ray system intended for radiographic/fluoroscopic applications, including cardiac, vascular, general diagnostic, and interventional x-ray imaging for General and Pediatric Populations. It is noted as the first FDA-approved AI-enabled X-ray system for cardiology.
Integrations
EHR Not specified
Specialties Cardiology, Interventional Radiology, Radiology

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Press & Coverage

Omega Medical Imaging
Omega Introduces Soteria.AI u2013 The Next Generational Leap in Interventional Cardiology Systems
Omega Medical Imaging announced the release of Soteria.AI, an FDA-approved AI-enabled X-ray system for cardiology that significantly reduces radiation dose by up to 84% while maintaining spectacular image quality. The system utilizes an AI-enabled automatic Region of Interest (ROI) and an ultra-fast secondary collimator for enhanced radiation protection.
2022-04
DAIC (Diagnostic and Interventional Cardiology)
Omega Introduces Soteria.AI Interventional Cardiology System | DAIC
Omega Medical Imaging launched Soteria.AI, an image-guided X-ray system for cardiology labs that offers up to 84% radiation dose reduction and superior image quality through its AI-enabled automatic ROI and patented C-Arm design. The system aims to set a new standard of care in interventional systems.
2022-04
AuntMinnie.com
Omega launches new x-ray system for cardiology | AuntMinnie
AuntMinnie.com reported on Omega Medical Imaging's release of Soteria.AI, an AI-enabled X-ray system for interventional cardiology that uses an AI-based region of interest to drive a secondary collimator, significantly lowering radiation dose. The system has received U.S. Food and Drug Administration (FDA) clearance.
2022-04
HCB News
Omega Medical Imaging unveils image-guided X-ray system for interventional cardiology
Omega Medical Imaging introduced Soteria.AI, the first FDA-approved, AI-enabled X-ray solution for cardiology, which reduces radiation exposure by up to 84% using AI-enabled automatic Region of Interest (ROI) detection and an ultra-fast secondary collimator. Its floor-mounted C-arm design provides projections similar to larger, more costly ceiling-mounted systems.
2022-04
Omega Medical Imaging
Artificial Intelligence in Cardiology u2013 Beyond Image Analysis
This editorial discusses the broader applications of AI in cardiology beyond image analysis, highlighting Omega's Soteria.AI system as an example where AI determines and controls aspects of medical procedures, such as establishing the region of interest, to reduce radiation exposure by up to 84%.
2022-06
FDA
Omega Medical Imaging, LLC December 14, 2021 John Newman Regulatory Specialist 3400 St. Johns Parkway, Suite 1020 Sanford, Flori - accessdata.fda.gov
An FDA 510(k) summary document details the Omega Soteria.AI (SSXI) system, model AI-100, which received clearance for radiographic/fluoroscopic applications in cardiac, vascular, general diagnostic, and interventional X-ray imaging for general and pediatric populations. The system includes the FluoroShield / CA-100S device for automated Region of Interest (ROI) to reduce exposure.
2021-12
Omega Medical Imaging
AI X-ray Technology Reduces Radiation by Over 60% - Omega Medical Imaging
A groundbreaking clinical study published in the American Journal of Gastroenterology demonstrated that Omega Medical Imaging's AI image-guided X-ray technology, which uses AI algorithms to identify the region of interest, achieved a median radiation dose reduction of over 60% for both patients and staff during image-guided endoscopic procedures.
2020-04
Omega Medical Imaging
Key Clinical Data - Omega Medical Imaging
Omega Medical Imaging's 'Key Clinical Data' page highlights studies demonstrating significant radiation reduction with their AI image-guided X-ray systems, including Soteria.AI. One study concluded a significant reduction in radiation across all modes and frame rates compared to competitors.
unknown

Videos

Product demos, reviews, and walkthroughs for Soteria.AI.

View all on YouTube

Frequently Asked Questions

Soteria.AI, from Omega Medical Imaging, is an AI-enabled X-ray system designed for cardiac catheterization labs that significantly reduces radiation exposure for both patients and staff by up to 84%. This is achieved through its AI-enabled automatic Region of Interest (ROI) and ultra-fast secondary collimator, while also providing superior image quality and enhanced patient access during interventional procedures.
Yes, the Omega Soteria.AI System is notably the first FDA-approved AI-enabled X-ray system specifically for cardiology. While specific data privacy protocols for this particular system are not detailed in the provided information, healthcare AI systems generally must adhere to strict regulations like HIPAA to protect sensitive patient information through robust security measures such as encryption and access controls.
Integrating AI like Soteria.AI may present challenges such as the need for adequate training for healthcare providers to effectively utilize the technology and ensuring seamless integration with existing clinical workflows. Physicians must also guard against over-reliance on AI to maintain their critical thinking skills and remain vigilant for potential algorithmic biases.
While direct AI-enabled X-ray system alternatives to Omega's Soteria.AI for interventional cardiology would require specific comparison, the broader healthcare AI market offers platforms like Butterfly Network and Caption AI for portable ultrasound, PathAI for digital pathology, and Microsoft Dragon Copilot for administrative automation. Other companies like Soteria (not Soteria.AI) offer healthcare cloud services or electronic medical records software.
Specific pricing details for the Omega Soteria.AI System are not publicly disclosed in the provided search results, as advanced medical imaging systems typically involve a significant capital investment. The overall cost implications for a cardiology lab would encompass the initial purchase, installation, staff training, ongoing maintenance, and potential operational savings derived from reduced radiation dose and improved procedural efficiency.
Soteria.AI delivers state-of-the-art image processing and unmatched image quality, which is vital for precise diagnosis and treatment during cardiac procedures. Its patented C-Arm design also provides superior projections and patient access, a capability often reserved for larger, more expensive ceiling-mounted systems, thereby enhancing procedural flexibility and efficiency.
Physicians should be aware of ethical considerations such as ensuring transparency in how AI systems arrive at their conclusions and addressing potential algorithmic biases that could disproportionately affect certain patient populations. It is crucial to remember that AI serves as a supportive tool, and maintaining physician autonomy and human judgment in clinical decision-making remains paramount.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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