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

The CS-series-FP system with the CA-100S / FluoroShield™ accessory is designed to reduce radiation exposure in radiographic and fluoroscopic imaging by utilizing a secondary dynamic collimator that focuses high-frequency imaging on a clinician-defined or auto-tracked Region of Interest (ROI) while providing lower-frequency peripheral context. This is achieved through a combination of hardware, including adjustable lead shutters and dedicated processing units, and software adapted for specific flat panel detectors, which together blend images to maintain diagnostic utility and reduce patient and operator dose.

The Omega Medical Imaging CS-series-FP Radiographic/Fluoroscopic Systems, when equipped with the optional CA-100S / FluoroShield™ (ROI Assembly), are designed to minimize radiation exposure to both patients and medical staff during a variety of x-ray imaging procedures. This is achieved through a secondary fast collimator system, the CA-100S, which operates in tandem with the system's primary collimator to further refine the x-ray beam to a specific Region of Interest (ROI). The CA-100S employs four independently adjustable lead blades to precisely define this smaller ROI. The core technology involves a sophisticated image processing technique that blends a live, high-frequency fluoroscopic image of the dynamically adjusted ROI with a lower-frequency refreshed image of the surrounding peripheral anatomy, maintaining situational awareness. This particular submission outlines the integration and adaptation of the CA-100S / FluoroShield™ for use with a Varex 2020 Flat Panel Detector (FPD), which is smaller (20cm x 20cm) than the predicate device's detector, necessitating specific software modifications to ensure optimal performance including adjustments to image resolution, frame rate, and the auto-ROI tracking algorithms. The scientific basis for the FluoroShield™ technology lies in its ability to optimize diagnostic image quality within the crucial ROI while significantly reducing radiation exposure to the less critical peripheral areas, leading to a substantial overall dose reduction. The system offers an Auto-ROI mode capable of automatically tracking the movement of medical instruments, such as catheters, minimizing the need for manual adjustments by the operator. Key components of the CA-100S system include the Shutter assembly, a ROI Electronics Unit (REU) for controlling operations and image blending, an Auto-ROI Processor (ARP) for analyzing images and calculating optimal ROI settings, and dedicated control panels. Clinical studies and extensive bench testing, which included Dose Area Product (DAP) meter measurements, have demonstrated notable reductions in radiation dose—up to 61.8% for patients and 59.4% for staff. These reductions were achieved without compromising the procedural effectiveness or the essential diagnostic image quality required for interventional tasks, all while preserving the visibility of important anatomical landmarks in the periphery.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the performance of the Auto-ROI tracking algorithm with the Varex 2020 FPD compare to the Varex 3030 FPD, particularly in complex anatomical regions or with rapid instrument movement?; What is the quantitative impact on diagnostic image quality within the ROI when using the blended imaging technique compared to full-field, continuous fluoroscopy, particularly for subtle pathologies?; Are there specific interventional procedures where the benefits of the CA-100S / FluoroShield™ system's dose reduction are most pronounced or, conversely, where its application might be limited?; What is the learning curve for clinicians to effectively utilize the manual and auto-ROI features, and how does it integrate into existing procedural workflows?; Beyond DAP reduction, what are the specific organ dose sparing effects for patients and critical scatter radiation reductions at different staff positions when using this dynamic secondary collimation system?