510(k) K070542

CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS by Digirad Corp. — Product Code KPS

K070542 is an FDA 510(k) premarket notification submitted by Digirad Corp. for the device "CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS". The FDA issued a decision of Substantially Equivalent on March 23, 2007. 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.