SIENET DIAGNOSTIC REPORTING CONSOLE

SIENET DIAGNOSTIC REPORTING CONSOLE is an FDA 510(k)-cleared medical device (K920309) manufactured by Siemens Gammasonics, 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 March 19, 1992. Regulation: 8.