510(k) Report

Devices descending from K062384

7 later devices reach Cesium-131 Strand, Strand Preload, Preload, S-Cartridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092458Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18…Isoray Medical, Inc.20091—
+1K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc.20094—
+2K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.20200—
+2K180515GammaTileIsoray Medical, Inc.20183—
+3K190296GammaTileGt Medical Technologies20192—
+4K190839GammaTileGt Medical Technologies20201—
+5K221539GammaTileGt Medical Technologies20220—