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Ziehm Imaging Receives US FDA Approval For Ziehm Vision RFD

Ziehm Imaging announced that it has received US FDA 510(k) clearance for its Ziehm Vision RFD to begin marketing and sales within the US. The Ziehm Vision RFD has been designed for use in endovascular surgery, interventional cardiology and interventional radiology. It delivers exceptional image quality by combining the latest flat-panel technology and digital imaging chain. During demanding procedures physicians will benefit from improved visualization, workflow and reduced radiation dose. The company will present Ziehm Vision RFD at the SVS congress in Denver, Co from June 11-13.

The Ziehm Vision RFD provides excellent image quality at an minimal dose by combining innovative flat-panel technology with the sophisticated ODDC (Object Detected Dose Control) software and special designed anatomical programs. The 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 165degrees orbital rotation. The pulse technology at up to 25 frames per second, the system provides sharp, high contrast images of vasculature, bone and soft tissue structures, which is indispensable particularly for complex applications in endovascular surgery. The excellent image quality, once only expected from fixed room systems, is now available in a mobile interventional suite.

The Ziehm Vision RFD provides physicians with a wide range of benefits with its compact design and the flat panel detector’s increased field of view. The flat panel detector 30 cm x 30 cm size and the 1.5 k x 1.5 k resolution provides extended dynamic range and 49% greater anatomical viewing, when compared to 12 inch image intensifier systems delivering comprehensive information about the patient’s anatomy. Users receive the benefit of greater maneuverability with the smaller footprint. At the same time, the mobile interventional suite provides better access to the patient due to the larger C-arm opening and the 165degrees orbital rotation. Additionally with the Ziehm Vision RFD, user workflow is simplified and day-to-day clinical efficiency is improved through the innovative VisionCenter touchscreen user interface. Ziehm Vision RFD is suitable for a wide variety of clinical tasks because of its excellent image quality and user friendliness particularly for demanding procedures common in endovascular surgery, interventional radiology, and interventional cardiology.