510(k) K030085

CARDIUS-1 AND CARDIS-2 by Digirad Corp. — Product Code KPS

K030085 is an FDA 510(k) premarket notification submitted by Digirad Corp. for the device "CARDIUS-1 AND CARDIS-2". The FDA issued a decision of Substantially Equivalent on February 5, 2003. 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.