ImaCor Zura Handheld ZHH-010

ImaCor Zura Handheld ZHH-010 is an FDA 510(k)-cleared medical device (K220490) manufactured by Imacor, 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 April 7, 2022. Regulation: 8.