C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner

C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner is an FDA 510(k)-cleared medical device (K211001) manufactured by Medtec, Inc. Dba Civco Medical Solutions and Civco. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 19, 2021. Regulation: 8.