510(k) Report

Devices descending from K914281

32 later devices reach I-125 Seeds, Code: 6711 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140849IsoseedEckert & Ziegler Bebig GmbH20140—
+1K103319I-SEEDTheragenics Corp.20110—
+1K081066Brachytherapy Source Device, Model 9011Medi-Physics, Inc., Dba GE Healthcare20080—
+1K030594I-125 Rapid Strand, Model 7000Amersham Health200317—
+1K023242I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-SterileImplant Sciences Corp.20020—
+1K994317I-Plant, Model 3500Implant Sciences Corp.20002—
+1K992963I3RAD 125 I Brachytherapy Seed, Model I125-0401International Isotopes, Inc.19990—
+1K991526Isostar I-125 Interstitial Seed, Model IS-12501Imagyn Medical Technologies, Inc.19990—
+1K984235Intersource 125, Model 1251LInternational Brachytherapy, Inc.19999—
+1K990193Iodine Brachytherapy Seeds, Model 3000Implant Sciences Corp.19994—
+1K984446`BI I-125 Brachytheraphy Seed, Model 125SL & 125SHUrocor, Inc.19990—
+1K982421Imagyn 125 I Seed, Model IS 125International Isotopes, Inc.19986—
+2K141038Ant Model 1Advanced Nuclide Technologies, LLC20140—
+2K090366Spec Model M-31Source Production & Equipment Co., Inc.20091—
+2K063177Rapid Strand RXOncura, Inc.200611
+2K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc.20067—
+2K053595Curay Custom Seed ArrayBiolucent, Inc.20060—
+2K041702EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)Ibt SA20048—
+2K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH200414—
+3K122764Rapid Strand RXMedi-Physics, Inc.20120—
+3K113210Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC20121—
+3K091117Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model IaslbkaIsoaid, LLC20090—
+3K092458Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18…Isoray Medical, Inc.20091—
+3K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc.20094—
+3K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp.200701
+3K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp.20059—
+4K242818IsoSphereIsoaid, LLC20250—
+4K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.20200—
+4K180515GammaTileIsoray Medical, Inc.20183—
+5K190296GammaTileGt Medical Technologies20192—
+6K190839GammaTileGt Medical Technologies20201—
+7K221539GammaTileGt Medical Technologies20220—