Soteria E-View
Overview
Soteria E-View by Omega Medical Imaging is an advanced AI-guided interventional fluoroscopic X-ray system specifically engineered for interventional endoscopy, including ERCP and image-guided endoscopic GI procedures. [3, 4] This system integrates Omega’s proprietary FluoroShield™ AI-powered radiation reduction technology, which significantly minimizes X-ray exposure for both patients and medical staff by up to 84%. [3, 6, 14, 22]
The system features a highly responsive CMOS detector for enhanced visualization of vessels and catheters, and a motorized patient table with a capacity of up to 800 lbs, designed for optimal patient positioning during complex procedures. [2, 3] Its unique design includes a rotatable C-arm with telescoping SID and 360-degree lead shielding protection on the flat panel detector and below the table, further reducing scatter radiation. [2, 3] Soteria E-View is designed for ease of operation with an intuitive control panel, allowing independent movements of the C-arm and table, and is compatible with images from other modalities via DICOM. [3, 4]
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI image-guided Region of Interest (ROI) modality system for radiation reduction (up to 84%) [3, 6, 14, 22]
- FluoroShieldu2122 AI-powered radiation reduction technology [3, 6, 22]
- Designed specifically for ERCP and image-guided endoscopic GI procedures [3, 4]
- Motorized patient table with up to 800 lbs weight capacity [3]
- Rotatable C-ARM with telescoping SID for versatile positioning [2, 3]
- 360-degree lead shielding protection on flat panel detector and below the table [3]
- Intuitive control panel for independent C-arm and table movements [3]
- Highly responsive CMOS detector for advanced feature detectability and enhanced vessel visualization [2]
- Compatibility to images of other modalities via DICOM [4]
- Built-in radiation safety controls with FDA cleared CA-100S /FluoroShield (K182834) [4]
Use Cases
- ERCP procedures [3, 4]
- Image-guided endoscopic GI procedures [3, 4]
- General radiographic/fluoroscopic diagnostic imaging [4]
- Interventional X-ray imaging for General and Pediatric Populations [4]
- Minimally invasive procedures on obese and high-risk patients [22]
What Physicians Need to Know
Leverage Soteria E-View's real-time AI-guided fluoroscopy to enhance precision and safety during complex interventional GI procedures, particularly ERCP. Utilize the FluoroShieldu2122 technology to significantly reduce radiation exposure for both patients and the clinical team, improving long-term safety profiles. Integrate the system's image storage and post-processing capabilities for comprehensive procedure documentation and review. Its compatibility with existing endoscopy systems and DICOM ensures a streamlined workflow for image-guided interventions.
Soteria E-View is designed to integrate seamlessly within interventional endoscopy suites, supporting ERCP and other image-guided GI procedures. Its DICOM compatibility facilitates the exchange of images with other medical imaging systems and patient record platforms. The system's multi-display solutions and configurable video manager options allow for flexible integration with various endoscopic equipment and viewing setups.
Details
| Category | Gastroenterology AI, Radiology & Imaging AI, Surgical AI |
| Pricing | Contact vendor — Not specified; contact vendor for pricing information. |
| Deployment | On-premise |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The Soteria E-View interventional fluoroscopic X-ray system received Traditional 510(k) clearance (K242488) on January 6, 2025. It is intended for radiographic/fluoroscopic applications, including gastrointestinal, ERCP, general diagnostic, and interventional X-ray imaging for General and Pediatric Populations. [4] |
| Integrations | |
| EHR | Not specified |
| Specialties | Gastroenterology, Interventional Radiology |
What the Web Says
The Soteria E-View, developed by Omega Medical Imaging, is an AI-powered fluoroscopic X-ray system designed for interventional endoscopy, particularly ERCP and image-guided GI procedures. It aims to significantly reduce radiation exposure for both patients and medical staff while maintaining high image quality. The system utilizes AI image-guided technology with a secondary, ultrafast collimator to automatically identify and focus on the region of interest, blocking radiation to peripheral areas.
Overall: PositiveStrengths
- Significant reduction in radiation exposure (up to 84%) for patients and staff due to AI-enabled collimation.
- Superior image quality for precise diagnosis and treatment.
- AI image-guided Region of Interest (ROI) automatically adjusts, reducing cognitive burden on physicians and enhancing workflow.
- Designed specifically for ERCP and image-guided endoscopic GI procedures.
- Compact design and flexible C-arm allow for versatile positioning and patient access.
- Rapid installation compared to larger, ceiling-mounted systems.
Limitations
- Limited independent physician or tech reviewer opinions available outside of company-sponsored content or FDA filings.
- No readily available information on pricing or cost-effectiveness compared to competitors.
- Lack of detailed user reviews on platforms like Reddit, G2, or Capterra.
- The system is an evolution of a previous model (Soteria.AI), suggesting potential for ongoing refinements.
Based on reviews from: accessdata.fda.gov, omegamedicalimaging.com, daic.com, vertexaisearch.cloud.google.com
Last updated: 2026-07-19
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