UNIVERSAL SYSTEM, MODEL QV-800

UNIVERSAL SYSTEM, MODEL QV-800 is an FDA 510(k)-cleared medical device (K023008) manufactured by Quantum Medical Imaging, 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 12, 2002. Regulation: 8.