510(k) K161984

Interlocked Circular Small Field Collimators, Elekta Integrated by Aktina Medical Corporation — Product Code IYE

K161984 is an FDA 510(k) premarket notification submitted by Aktina Medical Corporation for the device "Interlocked Circular Small Field Collimators, Elekta Integrated". The FDA issued a decision of Substantially Equivalent on Sep 27, 2016. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Aktina Medical Corporation has 2 other 510(k) clearances on record.