Viz HDS, Viz Volume Plus, Viz ICH+

Viz HDS, Viz Volume Plus, Viz ICH+ is an FDA 510(k)-cleared medical device (K232363) manufactured by Viz. Ai, 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 4, 2024. Regulation: 8.