
Digirad Corp.
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CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS is an FDA 510(k)-cleared medical device (K070542) manufactured by Digirad Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 22, 2007. Regulation: 8.