
X-Cel X-Ray Corp.
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IDX-60 INTRAORAL X-RAY is an FDA 510(k)-cleared medical device (K993958) manufactured by X-Cel X-Ray Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 2000. Regulation: 8.