SIR-Spheres Microspheres Activity Calculator (SMAC)

SIR-Spheres Microspheres Activity Calculator (SMAC) is an FDA 510(k)-cleared medical device (K202392) manufactured by Sirtex Medical US Holdings, 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 October 22, 2020. Regulation: 8.