Kubtec Receives Pre-market Approval for Radiography Device

Kubtec has received approval to market its XPERT 40 digital specimen radiography device from the FDA. The 510(k) premarket approval notification adds to the CE, CSA, Health Canada and CDRH certifications that have already been obtained for the device.
The XPERT 40 is available with the largest variety of digital detectors for specimen radiography, including an 8-by-8 inch (200-by-200 millimeter) detector with over 65,000 shades of gray (16 bit grayscale) and DICOM 3.0 compliant software. The new DICOM software suite enables the user to acquire an image in a few seconds. Acquired images can be processed at the workstation or sent directly to PACS. Systems and components along with local support are available around the world.