ImagenSPECT 3.0

ImagenSPECT 3.0 is an FDA 510(k)-cleared medical device (K201933) manufactured by Cardiovascular Imaging Technologies. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 10, 2020. Regulation: 8.