SOFTWARE PROGRAM USED W/PRISM PRODUCTS

SOFTWARE PROGRAM USED W/PRISM PRODUCTS is an FDA 510(k)-cleared medical device (K904978) manufactured by Prism Imaging, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 1991. Regulation: 8.