510(k) K082798

DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 by Medicatech USA — Product Code KPR

K082798 is an FDA 510(k) premarket notification submitted by Medicatech USA for the device "DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000". The FDA issued a decision of Substantially Equivalent on October 28, 2008. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Medicatech USA has at least 9 other 510(k) clearances on record.