INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR

INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR is an FDA 510(k)-cleared medical device (K130549) manufactured by Carl Zeiss Meditec, 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 June 25, 2013. Regulation: 8.