
Rf Systems Lab.
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DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI is an FDA 510(k)-cleared medical device (K062376) manufactured by Rf Systems Lab.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2006. Regulation: 8.