2D, 3D TOF MR ANGIOGRAPHY

2D, 3D TOF MR ANGIOGRAPHY is an FDA 510(k)-cleared medical device (K935671) 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 March 29, 1994. Regulation: 8.