SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR

SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR is an FDA 510(k)-cleared medical device (K043002) manufactured by Sedecal., Sa.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2004. Regulation: 8.