510(k) K092105

RADIANALYZER XPRESS by Radi Medical Systems AB — Product Code DQK

K092105 is an FDA 510(k) premarket notification submitted by Radi Medical Systems AB for the device "RADIANALYZER XPRESS". The FDA issued a decision of Substantially Equivalent on October 9, 2009. 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.