
Medtronic Navigation, Inc. (Littleton)
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O-ARM IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K092564) manufactured by Medtronic Navigation, Inc. (Littleton). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 2010. Regulation: 8.