AERODR SYSTEM WITH P-21

AERODR SYSTEM WITH P-21 is an FDA 510(k)-cleared medical device (K113248) manufactured by Konica Minolta Medical & Graphic, 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 January 16, 2012. Regulation: 8.