510(k) K051549

CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM by Digirad Corp. — Product Code KPS

K051549 is an FDA 510(k) premarket notification submitted by Digirad Corp. for the device "CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 13, 2005. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Digirad Corp. has at least 10 other 510(k) clearances on record.