MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT

MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT is an FDA 510(k)-cleared medical device (K925956) manufactured by Nucletron-Oldelft Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 1993. Regulation: 8.