Search Results

The intended use of the proposed GE Imatron e-Speed EBT Scanner System remains unchanged from the intended uses of prior predicate Imatron devices and other scanners. The e-Speed is designed -- as are all predicate devices -- to produce cross sectional images of the entire human anatomy. Specifically, the e-Speed is intended: - to permit radiologic visualization of the heart, blood vessels, or lymphatic system, during or after injection of a contrast medium; - to function as a diagnostic x-ray system to produce two and three dimensional images of the heart, blood vessels, or lymphatic system from a volume of computer reconstructed cross-sectional images from x-ray transmission data from the same axial plane taken at different angles; - to permit the data from certain three dimensional images to also be presented in time-sequenced or cine fashion; - to permit the data from three dimensional images to be viewed from a point of view moving inside the tissue, called "fly-through" mode for colons, blood vessels, or airways; - to be used for clinical situations requiring determination of specific quantitative information, such as the determination of calcium or other materials in bone, tumors, or organs; - to be used by the physician as an aid in the diagnosis of lung pathology; - for real-time motion studies, vascular and tissue blood flow analysis, and full three-dimensional volume imaging. The e-Speed will make use of previously cleared workstation software products and software applications. Finally, such system is intended to be used in a manner consistent with those devices already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.

The e-Speed EBT Scanner System ("e-Speed") is composed of a Gantry/Front End Assembly, Rear Electrical/Mechanical Assembly with Electron Source, Patient Table, Operator Console, Computer, HV Power Supply and Power Conditioning and Distribution System, water chiller, and associated accessories. Materials: Materials and construction are equivalent to the C150XP EBT Scanner System (K001550) and are compliant with UL2601-1, IEC 60601-1, and 21CFR Subchapter J. Design: The system is designed to be an angiographic X-ray system, and a whole body CT scanner utilizing electron beam technology, a modernized beam control system and redesigned x-ray data acquisition system, a higher power HV supply, an operator console, and the capability to scan at 0.050 sec as the primary mode of operation.