510(k) K161724

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) by Radiomed Corporation — Product Code IYE

K161724 is an FDA 510(k) premarket notification submitted by Radiomed Corporation for the device "Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)". The FDA issued a decision of Substantially Equivalent on Apr 28, 2017. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Radiomed Corporation has 4 other 510(k) clearances on record.