CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield� (ROI Assembly)
Omega Medical Imaging, LLCThe CS-series-FP Radiographic / Fluoroscopic System with the optional CA-100S / FluoroShield ROI Assembly is an advanced fluoroscopic X-ray system that automatically manages and reduces radiation exposure by focusing on a configurable region of interest (ROI) during imaging. It blends high-resolution live imaging of the ROI with lower-exposure peripheral imaging, thus improving image quality and reducing unnecessary radiation dose to both patients and medical staff during interventional procedures.
Intended Use
The CS-series-FP (SSXI) systems with optional accessory device CA-100S provide an automated region of interest that reduces exposure to the patient and operator. Intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional X-ray imaging for general populations. Not a replacement for the primary collimator, which defines the ROI.
Technology
The system includes a secondary fast collimator (CA-100S / FluoroShield™) comprising a shutter, ROI electronics unit, an Auto-ROI processor, and control panels. It automatically adjusts the ROI based on image analysis to reduce field of view and scatter, while blending the ROI with a lower-exposure background peripheral image. It integrates with a flat panel detector and X-ray system, providing real-time ROI tracking and dose reduction.
Performance
Performance testing included bench testing comparing the CA-100S with different flat panel detectors, clinical studies with 100 patients demonstrating dose reduction, and validation of ROI tracking and image blending. Clinical results showed up to 61.8% dose reduction in patients and 59.4% reduction to staff, with no compromise in image quality or procedural workflow.
Predicate Devices
No predicate devices specified
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