3D TOF ANGIOGRAPHY MEASURING FUNCTION

3D TOF ANGIOGRAPHY MEASURING FUNCTION is an FDA 510(k)-cleared medical device (K920441) 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 July 29, 1992. Regulation: 8.