16ch Foot/ Ankle SPEEDER

16ch Foot/ Ankle SPEEDER is an FDA 510(k)-cleared medical device (K181697) 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 July 10, 2018. Regulation: 8.