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Digirad Corp.
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CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K052430) 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 October 3, 2005. Regulation: 8.