CURA 16; ScintCare CT16

CURA 16; ScintCare CT16 is an FDA 510(k)-cleared medical device (K173076) manufactured by Fmi Medical Systems, 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 3, 2018. Regulation: 8.