510(k) K021656

HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 by Nuclear Diagnostics — Product Code KPS

K021656 is an FDA 510(k) premarket notification submitted by Nuclear Diagnostics for the device "HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4". The FDA issued a decision of Substantially Equivalent on June 13, 2002. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Nuclear Diagnostics has at least 10 other 510(k) clearances on record.