DIVA ZSP2105CMI with QUBYX PerfectLum bundle

DIVA ZSP2105CMI with QUBYX PerfectLum bundle is an FDA 510(k)-cleared medical device (K160328) manufactured by The Linden Group Corp. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 2016. Regulation: 8.