DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)

DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) is an FDA 510(k)-cleared medical device (K132261) manufactured by Ge Medical Systems, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2013. Regulation: 8.