KRYSTALRAD 560 (FLAATZ 560)

KRYSTALRAD 560 (FLAATZ 560) is an FDA 510(k)-cleared medical device (K102284) manufactured by Medicatech USA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 2011. Regulation: 8.