CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

by Omega Medical Imaging  · Based in United States → — AI Image-Guided Interventional Systems that reduce radiation exposure.
Cardiology Interventional Radiology Vascular Surgery
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Regulatory Status Disclosed

Overview

The Omega Medical Imaging CS-series-FP Radiographic / Fluoroscopic Systems, with the optional CA-100S / FluoroShield™ (ROI Assembly), are advanced medical imaging devices designed for interventional X-ray procedures. These systems incorporate Artificial Intelligence (AI) to enhance image guidance and significantly reduce radiation exposure for both patients and medical staff. The FluoroShield™ technology, specifically, utilizes AI and an ultra-fast collimator to define a Region of Interest (ROI), concentrating X-ray dosage on the target area while safeguarding surrounding anatomy. This results in a reported radiation exposure reduction of up to 84% without compromising image quality or workflow. The systems offer crystal-clear images in both cine and fluoro modes, supporting better diagnosis and treatment in various clinical applications.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered Region of Interest (ROI) imaging
  • FluoroShieldu2122 radiation reduction technology
  • Up to 84% reduction in radiation exposure
  • TruBlocku2122 technology for precise collimation
  • Advanced image processing for clear images
  • Cine and fluoro modes
  • DICOM compatibility
  • Single and dual plane configurations
  • Motorized C-arm positioning
  • Patient table with elevation and tilt options

Use Cases

  • Cardiac interventional procedures
  • Vascular interventional procedures
  • General radiographic/fluoroscopic diagnostics
  • Interventional X-ray imaging
  • Endoscopic procedures (e.g., ERCP)

What Physicians Need to Know

DICOM Support & Standards
The CS-series-FP systems, which integrate with FluoroShieldu2122, are DICOM compatible, enabling standard image and information exchange.
PACS Integration Method
Integration with PACS is achieved through standard DICOM compatibility, allowing for seamless transfer of acquired images and patient information.
Reading Room Workflow Impact
The AI-enabled FluoroShieldu2122 system optimizes workflow by intuitively detecting the Region of Interest (ROI) and automatically collimating, reducing radiation exposure without interrupting the interventionalist's focus. It helps clinicians achieve ALARA (as low as reasonably achievable) goals.
AI Model Architecture (deep learning approach)
The system utilizes an AI-powered approach to detect the Region of Interest (ROI) and automatically control collimation for radiation reduction. Specific deep learning architectures (e.g., CNN, RNN) are not disclosed.
FDA Clearance Pathway (510k/De Novo)
The FluoroShieldu2122 (CA-100S) received 510(k) clearance from the FDA, indicating substantial equivalence to legally marketed predicate devices. Multiple 510(k) clearances are associated with the CS-series-FP and its accessories (e.g., K191713, K182834, K171755, K121293, K070834).
Supported Modalities (CT/MRI/X-ray/US)
The system is designed for radiographic and fluoroscopic applications, specifically for interventional X-ray imaging, including cardiac, vascular, and general diagnostic procedures. It does not support CT, MRI, or Ultrasound.
RSNA/ACR Validation
No specific RSNA or ACR validation data is mentioned in the provided information.
Physician Tip

Leverage the AI-powered FluoroShieldu2122 to significantly reduce radiation exposure for both patients and staff during interventional X-ray procedures, helping to meet ALARA goals. The system's intuitive ROI detection and auto-collimation minimize workflow disruption, allowing for continued focus on patient care while maintaining critical peripheral anatomical views. This technology is particularly beneficial for high-volume interventional programs and can expand eligibility for minimally invasive procedures to a wider range of patients, including those who are obese or high-risk.

The CS-series-FP system, with its FluoroShieldu2122 option, offers standard DICOM compatibility for integration with existing PACS and other imaging systems. This ensures seamless transfer of images and patient data within the radiology workflow.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Unknown
DeploymentOn-premise hardware system installed in hospitals and healthcare facilities.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Omega Medical Imaging CS-series-FP systems received FDA 510(k) clearance (K070834). The optional CA-100S / FluoroShield™ (ROI Assembly), which provides AI-powered radiation exposure reduction, received separate 510(k) clearance (K191713) as a modification device.
Integrations
EHR Not specified
Specialties Cardiology, Interventional Radiology, Vascular Surgery

What the Web Says

The Omega Medical Imaging CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShieldu2122 (ROI Assembly) is an FDA-cleared system designed for various radiographic and fluoroscopic applications, including cardiac, vascular, and general diagnostic and interventional x-ray imaging. A key feature, FluoroShieldu2122, utilizes AI and an ultra-fast collimator to reduce radiation exposure for both patients and staff by up to 84% while maintaining a full field of view with a blended image. The system aims to enhance image quality, improve workflow, and prioritize patient and staff safety through advanced radiation dose management.

Overall: Positive

Strengths

  • Significant reduction in radiation exposure for both patients and staff (up to 84%) due to AI-powered FluoroShieldu2122 and automatic secondary collimation.
  • Maintains full field of view while reducing radiation by blending a live ROI image with a lower-frequency refreshed peripheral image.
  • Improved image quality through auto-collimation, reduced X-ray scatter, and advanced image processing.
  • Designed for a wide range of radiographic/fluoroscopic applications, including cardiac, vascular, and general interventional procedures.
  • Automated, hands-free operation for radiation reduction, seamlessly integrating into existing workflows.
  • Complies with international safety standards and FDA regulations.

Limitations

  • Limited independent user reviews available from physicians, healthcare IT, or tech reviewers on platforms like Reddit, G2, or Capterra.
  • Information primarily stems from official FDA documents and company press releases, which may not offer a fully unbiased perspective.
  • Specific details on integration with various healthcare IT systems are not extensively detailed in the available information.
  • No direct feedback on user-friendliness or potential learning curves from external sources.
  • No information regarding pricing or cost-effectiveness compared to competitor systems.

Based on reviews from: Omega Medical Imaging, LLC (FDA 510(k) Premarket Notification), Radiology AI Directory Tools, DAIC (Diagnostic and Interventional Cardiology), Imaging Technology News

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

Imaging Technology News
Omega Medical Imaging Launches AI-enabled FluoroShield for Radiation Reduction
Omega Medical Imaging received FDA 510(k) clearance for its AI-powered FluoroShield, an ROI radiation exposure reduction solution for their flat panel detector CS-series product lines, capable of reducing radiation exposure by up to 84%.
2019-04
Omega Medical Imaging
Omega Medical Imaging launches FluoroShieldu2122 the first AI enabled Radiation Reduction Solution
Omega Medical Imaging announced the FDA 510(k) clearance of FluoroShieldu2122, an AI-powered Region of Interest (ROI) radiation exposure reduction solution for interventional X-ray imaging on their CS-series product lines, which can reduce radiation exposure by up to 84%.
2019-04
Omega Medical Imaging
First AI enabled ROI Radiation Reduction shutter technology FluoroShieldu2122 cleared by FDA
Omega Medical Imaging, in collaboration with IKOMED Technologies, launched FluoroShieldu2122, an AI-powered ROI radiation exposure reduction solution for their CS-series flat panel detector X-ray systems, demonstrating up to an 84% reduction in radiation exposure.
2019-04
PR Newswire
First AI Enabled ROI Radiation Reduction Shutter Technology FluoroShieldu2122 Cleared by FDA
Omega Medical Imaging and IKOMED Technologies announced the FDA clearance and launch of FluoroShieldu2122, an AI-powered ROI radiation reduction solution for interventional X-ray imaging on Omega's CS-series product lines, capable of reducing radiation exposure by approximately 84%.
2019-04
Medimaging.net
FDA Approves First AI-Powered Radiation Exposure Reduction Solution
The FDA has cleared FluoroShield, an AI-powered region of interest (ROI) radiation exposure reduction solution developed by Omega Medical Imaging and IKOMED Technologies, for interventional X-ray imaging on Omega's CS-series product lines, showing up to an 84% reduction in radiation exposure.
2019-04
Omega Medical Imaging
Omega Medical Imaging First in the World to Receive FDA Clearance on Artificial Intelligence Imaging System that Reduces Dose
Omega Medical Imaging announced FDA 510(k) clearance of FluoroShieldu2122 with their 2020 Cardiac Flat Panel Detector, highlighting its ability to provide an actual reduction in dose during interventional fluoroscopy or cine cases through auto-collimation and a blended image.
2019-10
BIBA Medtech Insights
Omega Medical Imaging become first-in-the world to receive FDA clearance on AI imaging system that reduces radiation
Omega Medical Imaging received FDA 510(k) clearance for its FluoroShield with their 2020 Cardiac Flat Panel Detector, a system that uses AI for auto-collimation and blended imaging to reduce radiation exposure during interventional procedures.
2019-10
Omega Medical Imaging
Technology Creates a New Standard of Care
A 2021 article from Omega Medical Imaging discusses how new AI technology, specifically their FluoroShield system, can significantly reduce radiation exposure to patients and staff during interventional endoscopy procedures, with one study showing a 59.4% reduction compared to non-AI systems.
2021-10

Videos

Product demos, reviews, and walkthroughs for CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly).

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Frequently Asked Questions

The AI in the CS-series-FP system, especially with FluoroShieldu2122, is designed to optimize image acquisition parameters and identify regions of interest (ROI) for targeted dose reduction. This technology has been shown to reduce radiation exposure by up to 84%, aiming to improve diagnostic image quality while minimizing patient and staff radiation exposure during fluoroscopic procedures.
The FluoroShieldu2122 AI-powered ROI radiation exposure reduction solution for interventional X-ray imaging has received 510(k) clearance from the U.S. FDA. Physicians should review specific regulatory statements to understand the validated applications and any associated responsibilities regarding interpretation and decision-making, as AI systems must comply with regulations like HIPAA and potentially the EU AI Act for high-risk medical devices.
AI algorithms, including those in the CS-series-FP system, may have limitations such as performance variations with atypical patient anatomies or pathologies not well-represented in training data. Potential biases can arise from insufficient or biased training data, which might lead to inaccurate or discriminatory outcomes. Physicians must exercise clinical judgment, as AI is an assistive tool and not a replacement for human expertise.
While specific comparisons require detailed product analysis, the AI in the CS-series-FP system with FluoroShieldu2122 is noted for its ability to combine AI, an ultra-fast collimator, and advanced image processing to reduce radiation exposure significantly. Physicians should evaluate its features against other systems based on their specific clinical needs, workflow integration, and evidence of performance in dose management and image quality.
The cost for AI features in medical imaging systems can range from $150,000 to $500,000, with enterprise-level integrations potentially reaching $1 million to $5 million. The projected ROI for AI in healthcare can include improved patient outcomes through reduced radiation dose, enhanced diagnostic confidence, and operational efficiencies, such as streamlined workflows and reduced administrative burden.
AI systems in healthcare must comply with strict regulations like HIPAA, which requires robust technical, administrative, and contractual safeguards for Protected Health Information (PHI). This typically involves secure data transmission and storage, encryption, access controls, and potentially de-identification of data, especially when AI models are trained on large datasets.
AI in radiology aims for seamless integration into existing Picture Archiving and Communication Systems (PACS) and Radiology Information Systems (RIS) to enhance workflow efficiency and reduce repetitive tasks. Effective utilization of advanced AI features typically requires comprehensive training for physicians and technologists, often provided by the vendor, to ensure proper use and to understand the AI's capabilities and limitations.

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