MINXRAY, MODELS HFP24 AND HFP40

MINXRAY, MODELS HFP24 AND HFP40 is an FDA 510(k)-cleared medical device (K060566) manufactured by Mikasa X-Ray Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 4, 2006. Regulation: 8.