RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY

RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY is an FDA 510(k)-cleared medical device (K981597) manufactured by Radionics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 8, 1998. Regulation: 8.