PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0

PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 is an FDA 510(k)-cleared medical device (K020436) 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 February 21, 2002. Regulation: 8.