MICROSELECTRON-HDR (HIGH DOSE RATE)

MICROSELECTRON-HDR (HIGH DOSE RATE) is an FDA 510(k)-cleared medical device (K864210) 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 25, 1986. Regulation: 8.