510(k) K982855

DIGIRAD 2020TC SPECT IMAGING SYSTEM by Digirad Corp. — Product Code KPS

K982855 is an FDA 510(k) premarket notification submitted by Digirad Corp. for the device "DIGIRAD 2020TC SPECT IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 4, 1998. 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.