ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL

ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL is an FDA 510(k)-cleared medical device (K896596) manufactured by Instrumentarium Imaging, 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 May 29, 1991. Regulation: 8.