EZSENSOR P DIGITAL INTRAORAL SENSOR

EZSENSOR P DIGITAL INTRAORAL SENSOR is an FDA 510(k)-cleared medical device (K121132) manufactured by Humanray 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 9, 2012. Regulation: 8.