5c96a1d0-d4c0-4e89-aa01-b6b84ed67bd9UpdatePublished42023-08-022017-03-07In Commercial DistributionB225100000040PrimaryHIBCCOrthoScan HD Mini C-arm1000-0004196554021Ziehm-Orthoscan, Inc.1Image-intensified fluoroscopic x-ray system, mobilefalsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse480-503-8010steve.seeman@orthoscan.comK05175400037649Portable general-purpose fluoroscopic x-ray system, digitalA portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.falseActiveOXOImage-Intensified Fluoroscopic X-Ray System, MobileJAASystem, X-Ray, Fluoroscopic, Image-IntensifiedHandling Environment TemperatureHandling Environment TemperatureHandling Environment HumidityHandling Environment Atmospheric Pressurefalsefalse