MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR

MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR is an FDA 510(k)-cleared medical device (K090526) manufactured by E-Woo Technology. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 2009. Regulation: 8.