DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A

DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A is an FDA 510(k)-cleared medical device (K140060) manufactured by Rayence 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 May 12, 2014. Regulation: 8.