
Electron Jsco.
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DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA is an FDA 510(k)-cleared medical device (K093640) manufactured by Electron Jsco.. 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 28, 2011. Regulation: 8.