XR90 (XR90-SYS)

XR90 (XR90-SYS) is an FDA 510(k)-cleared medical device (K223125) manufactured by Mediview Xr, 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 12, 2023. Regulation: 8.