BREAST SPEEDER CX, GRID HOLDER CX

BREAST SPEEDER CX, GRID HOLDER CX is an FDA 510(k)-cleared medical device (K142002) manufactured by Quality Electrodynamics, 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 August 21, 2014. Regulation: 8.