ART SHIELDED BREAST APPLICATOR

ART SHIELDED BREAST APPLICATOR is an FDA 510(k)-cleared medical device (K062135) manufactured by Advanced Radiation Therapy, LLC. 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 6, 2006. Regulation: 8.