HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL

HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL is an FDA 510(k)-cleared medical device (K894402) manufactured by Hipgraphics, 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 November 16, 1989. Regulation: 8.