510(k) Report

Devices descending from K940632

53 later devices reach I-125 Rapid Strand through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063177Rapid Strand RXOncura, Inc.200611
+1K061638Best Strand and Best SpacerBest Medical International, Inc.20060—
+1K030594I-125 Rapid Strand, Model 7000Amersham Health200317—
+1K023073Seed LinkImplant Sciences Corp.20031—
+1K013975CP-SleeveCp Medical20026—
+1K001070Radiomed SourceRadiomed Corp.200026—
+1K992262Indigo Prostate Seeding Needle Cartridge SystemIndigo Medical, Inc.19990—
+2K122764Rapid Strand RXMedi-Physics, Inc.20120—
+2K082159Civastring PD-103Civatech Oncology, Inc.20081—
+2K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc.20067—
+2K053595Curay Custom Seed ArrayBiolucent, Inc.20060—
+2K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH200414—
+2K034062CP Sleeve and River SleeveCp Medical20045—
+2K013660GenetraRadiomed Corporation200123—
+3K140490Civa Sheet PD-103Civatech Oncology, Inc.20140—
+3K113210Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC20121—
+3K103449Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical20113—
+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—
+3K022326Radiomed MarkerRadiomed Corporation200321—
+3K020683Isorod PD-103 Implant, Model Ati-PD-103Ati Medical, Inc.20020—
+4K242818IsoSphereIsoaid, LLC20250—
+4K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.20200—
+4K180515GammaTileIsoray Medical, Inc.20183—
+4K131689Mri MarkerC4 Imaging, LLC20131—
+4K120859Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation20120—
+4K031206Radiomed Soft Tissue MarkerRadiomed Corp.200320—
+5K190296GammaTileGt Medical Technologies20192—
+5K171487Sirius MRI Marker NSC4 Imaging, LLC20170—
+5K120796Superdimension Nitinol/Gold Fiducial MarkerSuperdimension, Inc.20121—
+5K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc.20089—
+5K071673Onc Solutions Marker, Models 001001 to 001012 and 001021 to 001032Onc Solutions, Inc.20073—
+5K070305Pre-Loaded VisicoilRadiomed Corporation200711—
+6K190839GammaTileGt Medical Technologies20201—
+6K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc.20180—
+6K173251LumiCoil Platinum Fiducial MarkerBoston Scientific Corporation20170—
+6K161724Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)Radiomed Corporation20171—
+6K160209Gold AnchorNaslund Medical AB20162—
+6K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc.20142—
+6K121663ClarityElekta, Ltd.20121—
+6K112841Surface Beacon TranspondersCalypso Medical Technologies, Inc.20120—
+6K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc.20114—
+6K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc.20106—
+6K091645Gold AnchorNaslund Medical AB20093—
+7K221539GammaTileGt Medical Technologies20220—
+7K201117Gold AnchorNaslund Medical AB20201—
+7K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…Varian Medical Systems, Inc.20150—
+7K141855ClarityElekta, Ltd.20140—
+7K123137Calypso SystemVarian Medical Systems20123—
+8K213053Gold AnchorNaslund Medical AB20220—