FDA grants Kubtec pre-market certification for Xpert 20

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Kubtec has received 510(k) clearance from the FDA to market its Xpert 20 digital specimen radiography device designed specifically for the biopsy suite.

With a footprint of less than 10 inches x 12 inches, the Xpert 20 provides the ability to locate the smallest micro-calcifications in seconds, according to the Milford, CT-based company.

Additional features include: automatic exposure control, auto-calibration, automatic window leveling and the ability to send multiple images, with annotations to PACS. The Xpert 20 is available with the option of two digital detectors sizes, 2-inch x 2-inch or 2-inch x 4-inch, and has DICOM-compliant software.