SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)

SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) is an FDA 510(k)-cleared medical device (K964969) manufactured by GE Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 1997. Regulation: 8.