
Quantum Medical Imaging, LLC
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QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI is an FDA 510(k)-cleared medical device (K080905) 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 July 15, 2008. Regulation: 8.