FDA grants 501(k) clearance to Siemens ARCADIS Avantic
The FDA has granted Siemens Medical Solutions 510(k) clearance for the ARCADIS Avantic, a new mobile C-arm system. The latest in the family of products, the Avantic is suited for advanced imaging requirements in trauma and spine surgery, general surgery and urology, orthopaedic surgery and pain management, gastroenterology, and vascular surgery, the company said.
The Avantic has several advanced features including 20 kW of power; up to 250 mA output; a 13 inch image intensifier, which results in a generous field of view; reduced weight and smaller footprint requirements, especially useful in the operating room (OR); and a compact, swivelling operating panel with ergonomically shaped handles as well as color-coded brake and control elements.
The system also offers a selection of application-specific programs with Virtual Patient Anatomy (VPA) for optimal image quality and a number of documentation and archiving capabilities.
Based on syngo, Siemens' software platform for different modalities, the Avantic is designed to aid staffs in simplifying clinical practices. The system also offers multi-modality viewing and image processing, and a selection of up to 200 default examination parameters.
The ARCADIS Avantic is equipped with a digital imaging chain that generates and manages all image data at a resolution of 1024x1024 pixels from acquisition to documentation. Two 18-inch large flat monitors display both images as well as results in Digital Cine Mode (DCM) with up to 250 mA. Film sequences are acquired and stored at speeds of up to 30 frames per second.
According the Siemens the product is expected to be ready for delivery in September 2005.
The Avantic has several advanced features including 20 kW of power; up to 250 mA output; a 13 inch image intensifier, which results in a generous field of view; reduced weight and smaller footprint requirements, especially useful in the operating room (OR); and a compact, swivelling operating panel with ergonomically shaped handles as well as color-coded brake and control elements.
The system also offers a selection of application-specific programs with Virtual Patient Anatomy (VPA) for optimal image quality and a number of documentation and archiving capabilities.
Based on syngo, Siemens' software platform for different modalities, the Avantic is designed to aid staffs in simplifying clinical practices. The system also offers multi-modality viewing and image processing, and a selection of up to 200 default examination parameters.
The ARCADIS Avantic is equipped with a digital imaging chain that generates and manages all image data at a resolution of 1024x1024 pixels from acquisition to documentation. Two 18-inch large flat monitors display both images as well as results in Digital Cine Mode (DCM) with up to 250 mA. Film sequences are acquired and stored at speeds of up to 30 frames per second.
According the Siemens the product is expected to be ready for delivery in September 2005.