DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)

DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) is an FDA 510(k)-cleared medical device (K133030) manufactured by Invivo Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 2014. Regulation: 8.