DASI Dimensions (V1.0)

DASI Dimensions (V1.0) is an FDA 510(k)-cleared medical device (K231324) manufactured by Dasi Simulations. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 7, 2024. Regulation: 8.