
Sedecal USA, Inc.
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EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) is an FDA 510(k)-cleared medical device (K012663) manufactured by Sedecal USA, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2001. Regulation: 8.