510(k) K042628

MODIFICATION TO: RADIANALYZER, MODEL 12711 by Radi Medical Systems AB — Product Code DQK

K042628 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "MODIFICATION TO: RADIANALYZER, MODEL 12711". The FDA issued a decision of Substantially Equivalent on January 19, 2005. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Radi Medical Systems AB has at least 10 other 510(k) clearances on record.