510(k) K202267

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles by Isoray Medical, Inc. — Product Code KXK

K202267 is an FDA 510(k) premarket notification submitted by Isoray Medical, Inc. for the device "Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles". The FDA issued a decision of Substantially Equivalent on December 31, 2020. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Isoray Medical, Inc. has at least 4 other 510(k) clearances on record.