Ziehm's Vision RFD Mobile C-Arm Imaging System Cleared by FDA
June 10, 2009—Ziehm Imaging, Inc. (Orlando, FL) announced that the US Food and Drug Administration has granted 510(k) marketing clearance for the Ziehm Vision RFD, a mobile C-arm imaging system that is designed for use in endovascular, interventional radiology, and interventional cardiology procedures.
According to the company, the Ziehm Vision RFD combines flat-panel technology with object-detected dose-control software and specially designed anatomical programs for enhanced image quality with a minimal dose of radiation. The 30- X 30-cm flat-panel detector allows for fully digital, distortion-free imaging and better access to the patient due to the larger C-arm opening and the 165¡ orbital rotation. With pulse technology at up to 25 frames per second, the system provides sharp, high-contrast images of vasculature, bone, and soft tissue structures. The 1,500- X 1,500-pixel resolution provides extended dynamic range and 49% greater anatomical viewing compared to 12-inch image intensifier systems delivering comprehensive information about the patient's anatomy. The Ziehm Vision RFD's VisionCenter touchscreen user interface simplifies workflow and improves day-to-day clinical efficiency, the company stated.