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
Device Timeline
- 1
Submission
6/26/2019
3 months - 2
FDA Approval
10/4/2019
Other devices from Omega Medical Imaging, LLC
- Soteria E-View2025 • 510K
- Soteria.AI2021 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.