AcQMap High Resolution Imaging and Mapping System

AcQMap High Resolution Imaging and Mapping System is an FDA 510(k)-cleared medical device (K222209) manufactured by Acutus Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 16, 2022. Regulation: 8.