POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)

POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) is an FDA 510(k)-cleared medical device (K933664) 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 December 14, 1993. Regulation: 8.