CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is an FDA 510(k)-cleared medical device (K223290) manufactured by Sentiar, 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 13, 2023. Regulation: 8.