MRP -5000(1): VERSION 2.0 SOFTWARE

MRP -5000(1): VERSION 2.0 SOFTWARE is an FDA 510(k)-cleared medical device (K905832) manufactured by Summit World Trade Corp.. 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 24, 1991. Regulation: 8.