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GE wins clearance for third digital x-ray unitAlmost a year after gaining clearance for its digital chest x-ray system, Revolution XQ/i, GE Medical Systems has received the go-ahead for a general-purpose unit based on the same detectors. On Oct.
Almost a year after gaining clearance for its digital chest x-ray system, Revolution XQ/i, GE Medical Systems has received the go-ahead for a general-purpose unit based on the same detectors. On Oct. 12, the Food and Drug Administration cleared Revolution TX/i, a general radiography system, according to Milwaukee-based GE. The unit joins the companys three other digital offerings: Revolution XQ/i; SenoVision, its digital spot and stereotactic system; and Senographe 2000D, its full-field mammography product, which is cleared for sale in Europe but not in the U.S.
Revolution TX/i boasts a flat-panel, amorphous silicon cesium iodide detector that measures 41 x 41 cm and is manufactured from a single seamless thin-film-transistor array. Although it uses the same detector as XQ/i, Revolution TX/i is configured slightly differently than the chest unit, consisting of a table for general radiography work with the chest stand as an option, according to Kevin Hobert, global manager of digital x-ray and installed base. The unit is now in the early clinical trial stage, but GE plans to begin full production early next year. The system will sell for $400,000 to $650,000, depending on configuration.