Digital x-ray developer Medicatech USA has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two digital radiography (DR) systems.
The agency has cleared the company's KrystalRad 1100 and KrystalRad 3000 systems. KrystalRad 1100 is a U-arm system that provides fully automatic or manual positioning and can be floor- or wall-mounted. The system features a 17 x 17-inch cesium iodide DR panel.
KrystalRad 3000 is a full x-ray system with an elevating table, wall stand, and ceiling-mounted tube support. It can utilize fixed or wireless 17 x 17-inch DR detectors or a mix of 14 x 17-inch and 17 x 17-inch DR detectors, according to the company.
