510(k) K073632

INTUITION, MODEL 0170 by Arcoma AB — Product Code KPR

K073632 is an FDA 510(k) premarket notification submitted by Arcoma AB for the device "INTUITION, MODEL 0170". The FDA issued a decision of Substantially Equivalent on January 10, 2008. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Arcoma AB has at least 1 other 510(k) clearance on record.