2D TOF ANGIOGRAHY MEASURING FUNCTION

2D TOF ANGIOGRAHY MEASURING FUNCTION is an FDA 510(k)-cleared medical device (K925009) manufactured by Hitachi Medical Systems America, 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 February 11, 1993. Regulation: 8.