Dell UP3216Q with QUBYX PerfectLum bundle

Dell UP3216Q with QUBYX PerfectLum bundle is an FDA 510(k)-cleared medical device (K162196) manufactured by Qubyx Software Technologies, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 14, 2016. Regulation: 8.