INFX-8000V, V5.30

INFX-8000V, V5.30 is an FDA 510(k)-cleared medical device (K133535) manufactured by Toshibamedical Systems Corporation. 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 22, 2014. Regulation: 8.