ISYS 1 (U.S),ACCESSORY, NON-STERILE

ISYS 1 (U.S),ACCESSORY, NON-STERILE is an FDA 510(k)-cleared medical device (K131433) manufactured by Isys Medizintechnik GmbH. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2014. Regulation: 8.