FLOUROSPOT T.O.P.

FLOUROSPOT T.O.P. is an FDA 510(k)-cleared medical device (K961871) manufactured by Siemens Medical Solutions USA, 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 July 30, 1996. Regulation: 8.