Source, Brachytherapy, Radionuclide
FDA product code KXK · Class II (moderate risk) · 21 CFR 892.5730 · Radiology
151510(k) clearances
0PMA approvals
5recalls
Implantimplanted device
Manufacturers
- Implant Sciences Corp. 6
- Cp Medical 6
- Isoaid, LLC 6
- Worldwide Medical Technologies, LLC 6
- C.R. Bard, Inc. 5
- Isoray Medical, Inc. 5
- Syncor Pharmaceuticals, Inc. 4
- Theragenics Corp. 4
- Medi-Physics Inc. Dba Nycomed Amersham Imaging 4
- Source Production and Equipment Co., Inc. 4
- Varian Medical Systems, Inc. 3
- Sourcetech Medical, LLC 3
- Isoray, Inc. 3
- North American Scientific, Inc. 3
- Civatech Oncology, Inc. 3
- Bebig Isotopen-Und Medizintechnik GmbH 3
- Best Industries 3
- Alpha-Omega Services, Inc. 3
- Ibt SA 3
- Syncor Intl. Corp. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252296 | OncoPatchKXK · Traditional | Oncopatch, Inc. | 12/05/2025SE |
| K242818 | IsoSphereKXK · Traditional | Isoaid, LLC | 07/15/2025SE |
| K223465 | RadianceTx Radionuclide Brachytherapy SourceKXK · Traditional | Radiance Therapeutics, Inc. | 01/11/2023SE |
| K221539 | GammaTileKXK · Traditional | Gt Medical Technologies | 11/09/2022SE |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional | Isoray Medical, Inc. | 12/31/2020SE |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special | Lv Liberty Vision Corporation | 05/29/2020SE |
| K190839 | GammaTileKXK · Traditional | Gt Medical Technologies | 01/23/2020SE |
| K191324 | CivaDermKXK · Traditional | Civatech Oncology, Inc. | 09/20/2019SE |
| K190296 | GammaTileKXK · Special | Gt Medical Technologies | 03/13/2019SE |
| K180515 | GammaTileKXK · Traditional | Isoray Medical, Inc. | 07/06/2018SE |
| K171487 | Sirius MRI Marker NSKXK · Traditional | C4 Imaging, LLC | 08/25/2017SE |
| K163572 | LV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceKXK · Traditional | Lv Liberty Vision Corp. | 03/15/2017SE |
| K163206 | SMD-Sr90-DA Radionuclide Brachytherapy SourceKXK · Traditional | Salutaris Medical Devices, Inc. | 12/15/2016SE |
| K162573 | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy SourceKXK · Traditional | Source Production and Equipment Co., Inc. | 11/04/2016SE |
| K161396 | SPEC Model M23KXK · Traditional | Source Production and Equipment Co., Inc. | 08/17/2016SE |
| K161395 | SPEC Model M13KXK · Traditional | Source Production and Equipment Co., Inc. | 07/06/2016SE |
| K150895 | SPEC Model M16KXK · Traditional | Source Production and Equipment Co., Inc. | 06/19/2015SE |
| K150636 | VariSeed 9.0KXK · Traditional | Varian Medical Systems, Inc. | 05/08/2015SE |
| K142701 | SMD Sr90-1 Radionuclide Brachytherapy SourceKXK · Traditional | Salutaris Medical Devices, Inc. | 12/19/2014SE |
| K141701 | I-125 RSLN [Radioactive Seed and Localization Needle]KXK · Traditional | Isoaid, LLC | 12/05/2014SE |
| K142668 | Lesion-Loc Iodine I-125 Seed/NeedleKXK · Traditional | Intramedical Imaging, LLC | 11/21/2014SE |
| K141038 | Ant Model 1KXK · Traditional | Advanced Nuclide Technologies, LLC | 11/12/2014SE |
| K140490 | Civa Sheet PD-103KXK · Traditional | Civatech Oncology, Inc. | 08/29/2014SE |
| K140849 | IsoseedKXK · Abbreviated | Eckert & Ziegler Bebig GmbH | 07/02/2014SE |
| K140856 | Brachysource Seed Implants with Sourcecap Bioabsorbable CapsKXK · Special | C.R. Bard, Inc. | 05/02/2014SE |
| K132969 | Spec Model M15KXK · Traditional | Source Production & Equipment Co., Inc. | 01/02/2014SE |
| K132996 | Cesitrx, (Liquid CESIUM-131 Solution) for Use with Gliasite RTSKXK · Traditional | Isoray, Inc. | 12/17/2013SE |
| K131689 | MRI MarkerKXK · Traditional | C4 Imaging, LLC | 11/20/2013SE |
| K122704 | Best Localization Needle with I-125 SeedKXK · Traditional | Best Medical Intl. | 01/09/2013SE |
| K122764 | Rapid Strand RXKXK · Traditional | Medi-Physics, Inc. | 12/28/2012SE |
| K113210 | Advantage-Strand/Advantage-Load Brachytherapy KitKXK · Traditional | Isoaid, LLC | 08/10/2012SE |
| K120859 | Pre-Loaded Gold Visicoil CK MarkerKXK · Special | Radiomed Corporation | 04/19/2012SE |
| K111979 | Radioactive Seed Localization NeedleKXK · Traditional | Biocompatibles, Inc. | 10/18/2011SE |
| K111931 | Gliasite RTSKXK · Special | Isoray Medical, Inc. | 08/05/2011SE |
| K102811 | Aos Orion IR-192 Source CableKXK · Traditional | Alpha-Omega Services, Inc. | 06/02/2011SE |
| K103449 | Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersKXK · Abbreviated | Riverpoint Medical | 02/25/2011SE |
| K103319 | I-SeedKXK · Abbreviated | Theragenics Corp. | 01/03/2011SE |
| K100847 | Synthetic Seeding Spacer Model SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30KXK · Traditional | Biocompatibles, Inc. | 05/21/2010SE |
| K093663 | Radionuclide Brachytherapy SourceKXK · Special | C.R. Bard, Inc. | 12/23/2009SE |
| K092522 | ACU007SKXK · Traditional | Oncology Systems, Inc. | 11/20/2009SE |
| K091117 | Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model IaslbkaKXK · Traditional | Isoaid, LLC | 09/15/2009SE |
| K092458 | Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18…KXK · Special | Isoray Medical, Inc. | 08/28/2009SE |
| K092136 | Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5KXK · Special | Isoray Medical, Inc. | 08/07/2009SE |
| K090366 | Spec Model M-31KXK · Traditional | Source Production & Equipment Co., Inc. | 04/22/2009SE |
| K083274 | Worldwide Medical Technologies Anchor Marker, Marker Strand and MarkerKXK · Traditional | Biocompatibles, Inc. | 01/08/2009SE |
| K082159 | Civastring PD-103KXK · Traditional | Civatech Oncology, Inc. | 09/30/2008SE |
| K072296 | Poiint of Care Stranding System, Mode 1004-00KXK · Abbreviated | Theragenics Corp. | 09/26/2007SE |
| K071550 | Pre-Waxed Needles with Gold Fiduciary MarkersKXK · Abbreviated | Cp Medical | 07/18/2007SE |
| K062825 | Aos Marker SeedsKXK · Traditional | Alpha-Omega Services, Inc. | 05/22/2007SE |
| K070468 | Implant Sciences Corp. Model HDR 4454KXK · Special | Implant Sciences Corp. | 03/23/2007SE |
| K062214 | Brachysciences StrandportKXK · Traditional | Worldwide Medical Technologies, LLC | 03/01/2007SE |
| K063177 | Rapid Strand RXKXK · Traditional | Oncura, Inc. | 11/30/2006SE |
| K062384 | CESIUM-131 Strand, Strand Preload, Preload, S-CartridgeKXK · Special | Isoray, Inc. | 11/09/2006SE |
| K061638 | Best Strand and Best SpacerKXK · Traditional | Best Medical International, Inc. | 08/04/2006SE |
| K060679 | Surtrak Implantation KitKXK · Traditional | North American Scientific, Inc. | 04/21/2006SE |
| K060636 | PALLADIUM-103 Seed Implant Kits -MultipleKXK · Traditional | C.R. Bard, Inc. | 04/19/2006SE |
| K053595 | Curay Custom Seed ArrayKXK · Traditional | Biolucent, Inc. | 02/28/2006SE |
| K052024 | Nstrand Implantation KitKXK · Traditional | North American Scientific, Inc. | 09/07/2005SE |
| K043246 | Brachysource Brachytherapy Seed ImplantsKXK · Traditional | C.R. Bard, Inc. | 02/02/2005SE |
| K043596 | Theraload Custom Loaded Needles, Models 200 and 125.S06KXK · Special | Theragenics Corp. | 01/26/2005SE |
| K043336 | Optistrand, Model 1032SKXK · Traditional | Ibt SA | 01/21/2005SE |
| K042864 | Implant Sciences Corp, Model HDR-4140KXK · Traditional | Implant Sciences Corp. | 01/06/2005SE |
| K043117 | Best Radiopaque Strand; Best Radiopaque MarkerKXK · Traditional | Best Medical International, Inc. | 12/09/2004SE |
| K042786 | Best Model # 81-01 Series IR-192 SourcesKXK · Abbreviated | Best Medical International, Inc. | 11/18/2004SE |
| K040766 | Optisource, Model 1032PKXK · Traditional | International Brachytherapy S.A. | 07/22/2004SE |
| K041702 | Ez-Pak (Ez-Pak Is a Trademark of Ibt S.A.)KXK · Special | Ibt SA | 07/16/2004SE |
| K041576 | SourcelinkKXK · Special | C.R. Bard, Inc. | 07/02/2004SE |
| K040339 | Brachytherapy Strand DeviceKXK · Traditional | Bebig Isotopen-Und Medizintechnik GmbH | 04/08/2004SE |
| K033770 | Isoaid Advantage PD-103, Model IAPD-103AKXK · Traditional | Isoaid, LLC | 04/08/2004SE |
| K034062 | CP Sleeve and River SleeveKXK · Special | Cp Medical | 01/30/2004SE |
| K033781 | Bebig Isoseed I-125KXK · Special | Bebig Isotopen-Und Medizintechnik GmbH | 12/30/2003SE |
| K023179 | Readi-Strand, Model PsstrandKXK · Traditional | Worldwide Medical Technologies, LLC | 07/02/2003SE |
| K021360 | Scintillating Fiber Dosimeter (SFD), Model MT-SFD-1000KXK · Traditional | Med-Tec,Inc. | 06/10/2003SE |
| K022705 | Readi-Strand, Model PsstrandKXK · Traditional | Worldwide Medical Technologies, LLC | 06/09/2003SE |
| K030534 | Variseed 7.1KXK · Traditional | Varian Medical Systems | 05/21/2003SE |
| K022389 | Readi-Load System, Model PSS 1820RLKXK · Traditional | Worldwide Medical Technologies, LLC | 05/06/2003SE |
| K030594 | I-125 Rapid Strand, Model 7000KXK · Special | Amersham Health | 04/10/2003SE |
| K023073 | Seed LinkKXK · Traditional | Implant Sciences Corp. | 04/07/2003SE |
| K030162 | Lawrence Cserion, Model CS-1KXK · Abbreviated | Isoray, Inc. | 03/28/2003SE |
| K023210 | Seedlinks, Models 70301, 70302, 70303KXK · Traditional | Sourcetech Medical, LLC | 03/28/2003SE |
| K024183 | Alton PT StepperKXK · Traditional | Alton Design, LLC | 03/17/2003SE |
| K030745 | Gammamed 212 and 232 Source AssemblyKXK · Traditional | Varian Medical Systems | 03/12/2003SE |
| K010705 | OptidosKXK · Traditional | Ptw-New York Corp. | 03/11/2003SE |
| K020683 | Isorod PD-103 Implant, Model ATI-PD-103KXK · Traditional | Ati Medical, Inc. | 12/17/2002SE |
| K023242 | I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-SterileKXK · Special | Implant Sciences Corp. | 12/04/2002SE |
| K020337 | Readi-Strand; Model PsstrandKXK · Traditional | Worldwide Medical Technologies, LLC | 07/29/2002SE |
| K021311 | Synthetic Absorbable Seeding Spacers Made of Polydioxanone MaterialKXK · Traditional | Cp Medical | 07/13/2002SE |
| K021343 | Isoseeds I-125KXK · Traditional | Bebig Isotopen-Und Medizintechnik GmbH | 05/20/2002SE |
| K013975 | Cp-SleeveKXK · Traditional | Cp Medical | 02/22/2002SE |
| K013964 | Modification to Accu-Space Plain Gut Absorbable Seeding SpacersKXK · Special | Cp Medical | 01/24/2002SE |
| K013660 | GenetraKXK · Special | Radiomed Corporation | 12/05/2001SE |
| K010621 | Accu-Space Absorbable Seeding SpacersKXK · Traditional | Cp Medical | 09/04/2001SE |
| K011427 | Mbi PD-103 SL; Mbi PD-103 SHKXK · Traditional | Mills Biopharmaceuticals, Inc. | 08/31/2001SE |
| K011155 | Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031SKXK · Abbreviated | Ibt, Inc. | 07/12/2001SE |
| K011205 | Isoaid Iodine Brachtherapy Seeds, Model Advantage I-125KXK · Traditional | Isoaid | 07/10/2001SE |
| K011119 | Brachyseed PD-103 Models #PD1KXK · Abbreviated | Draximage, Inc. | 06/25/2001SE |
| K010283 | Theraseed(R) PALLADIUM-103 Implant; Model 200KXK · Traditional | Theragenics Corp. | 04/26/2001SE |
| K003206 | Gliasite Radiation Therapy System (RTS), Model 1020,1030,1040,8150,9005KXK · Traditional | Proxima Therapeutics, Inc. | 04/25/2001SE |
| K010821 | ECHOSEED/IODINE-125 Seeds, Model 6733KXK · Special | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 04/11/2001SE |
| K002429 | Select Seed I-125KXK · Traditional | Nucletron Corp. | 02/02/2001SE |
| K001070 | Radiomed SourceKXK · Traditional | Radiomed Corp. | 10/24/2000SE |
| K002446 | Re-Entrant Chamber, Model 1008 or 44DKXK · Traditional | Sun Nuclear Corp. | 10/23/2000SE |
| K001366 | Prostec 125I Branchytherapy SnapseedKXK · Traditional | Prostec, LLC | 09/19/2000SE |
| K001765 | Look Collagen Spacers, Model 1514BKXK · Traditional | Surgical Specialties Corp | 09/07/2000SE |
| K000475 | BrachyseedKXK · Traditional | Draximage, Inc. | 08/22/2000SE |
| K994018 | Pharmaseed, Model BT-125-3KXK · Traditional | Syncor Pharmaceuticals, Inc. | 07/17/2000SE |
| K994016 | Pharmaseed, Model BT-103-3KXK · Traditional | Syncor Pharmaceuticals, Inc. | 07/14/2000SE |
| K993701 | Pharmaseed, Model BT-125-2KXK · Traditional | Syncor International, Inc. | 06/09/2000SE |
| K993700 | Pharmaseed, Model BT-103-2KXK · Traditional | Syncor International, Inc. | 06/02/2000SE |
| K993552 | Isoseed PD-103KXK · Traditional | Bebig Isotopentechnik GmbH | 03/31/2000SE |
| K994317 | I-Plant, Model 3500KXK · Traditional | Implant Sciences Corp. | 03/21/2000SE |
| K991881 | 125-IMPLANT Seeds, Model STM1250KXK · Traditional | Sourcetech Medical, LLC | 03/16/2000SE |
| K993280 | Prostec 125I Brachytherapy SeedsKXK · Traditional | Prostec, LLC | 03/14/2000SE |
| K991571 | 10 Curie Irdium 192, CSN00100-192KXK · Traditional | Alpha-Omega Services, Inc. | 02/22/2000SE |
| K992007 | Pharmaseed, Model BT-103-1KXK · Traditional | Syncor Pharmaceuticals, Inc. | 01/14/2000SE |
| K992008 | Pharmaseed, Model BT-125-1KXK · Traditional | Syncor Pharmaceuticals, Inc. | 12/23/1999SE |
| K991344 | Worldwide Medical Technologies Seeding SpacersKXK · Traditional | Worldwide Medical Technologies, LLC | 11/05/1999SE |
| K991280 | 125 Implant Seeds, Model STM1251KXK · Traditional | Sourcetech Medical, LLC | 10/20/1999SE |
| K992262 | Indigo Prostate Seeding Needle Cartridge SystemKXK · Traditional | Indigo Medical, Inc. | 10/04/1999SE |
| K992963 | I3RAD 125 I Brachytherapy Seed, Model I125-0401KXK · Special | International Isotopes, Inc. | 09/21/1999SE |
| K991526 | Isostar I-125 Interstitial Seed, Model IS-12501KXK · Special | Imagyn Medical Technologies, Inc. | 06/17/1999SE |
| K984235 | Intersource 125, Model 1251LKXK · Traditional | International Brachytherapy, Inc. | 06/09/1999SE |
| K990193 | Iodine Brachytherapy Seeds, Model 3000KXK · Traditional | Implant Sciences Corp. | 05/20/1999SE |
| K982226 | Uromed Brachytheraphy IODINE-125 SourcesKXK · Traditional | Uromed Corp. | 05/13/1999SE |
| K984446 | `Bi I-125 Brachytheraphy Seed, Model 125SL & 125SHKXK · Traditional | Urocor, Inc. | 04/16/1999SE |
| K973328 | IntersourceKXK · Traditional | International Brachytherapy S.A. | 12/10/1998SE |
| K972271 | North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-AKXK · Traditional | Ml Strategies, Inc. | 10/28/1997SE |
| K964647 | North American Scientific (Nasi) 1-125 Radionuclide Brachytherapy SourceKXK · Traditional | North American Scientific, Inc. | 02/10/1997SE |
| K945983 | Bebig Inactive Ophthalmic Applicators for Iodine 125 SeedsKXK · Traditional | Bebig Trade, Inc. | 10/18/1995SE |
| K936086 | Sterile Video Camera Cover and DrapeKXK · Traditional | Micromedical Devices, Inc. | 03/17/1994SE |
| K931393 | Bebig Plaques RUM101-RUM114KXK · Traditional | Bebig, Inc. | 03/16/1994SE |
| K923697 | Radionuclide Catheters, Rnc-A, Rnc-G, Rnc-UKXK · Traditional | Radionics, Inc. | 12/13/1993SE |
| K932242 | Radioactive Samarium 145 Seeds/Sources #2341-2345KXK · Traditional | Best Industries | 07/27/1993SE |
| K930570 | Radioactive Palladium 103 Seeds/SourcesKXK · Traditional | Best Industries | 06/04/1993SE |
| K924261 | Radioactive CESIUM-131 Seeds/SourcesKXK · Traditional | Best Industries | 06/04/1993SE |
| K920880 | Brainscan Brachytherapy ModuleKXK · Traditional | Brainlab | 12/30/1992SE |
| K923130 | IR-192 Implant -- ModificationKXK · Traditional | Omnitron Intl., Inc. | 09/21/1992SE |
| K914825 | 1-125 EndoseedKXK · Traditional | Endo Technic Corp. | 03/19/1992SE |
| K915156 | I-125 Seeds Code: 6702KXK · Traditional | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 01/06/1992SE |
| K914281 | I-125 Seeds, Code: 6711KXK · Traditional | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 11/22/1991SE |
| K914268 | I-125 Seeds in Carrier, Code: 6720KXK · Traditional | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 11/22/1991SE |
| K910710 | Radioactive SeedsKXK · Traditional | Best Assoc. Corp. | 06/10/1991SE |
| K911775 | Omnicath Implanted Catheter and DepotKXK · Traditional | Omnitron Intl., Inc. | 05/08/1991SE |
| K902488 | Modified Cass SystemKXK · Traditional | Medical Instrumentation & Diagnostics Corp.(Midco) | 12/07/1990SE |
| K903465 | IR-192 ImplantKXK · Traditional | Rads S.L., Inc. | 10/12/1990SE |
| K902622 | Manan Prostate Seeding NeedleKXK · Traditional | Manan Medical Products, Inc. | 08/10/1990SE |
| K896197 | Colab Cocath(Tm) Implanted Catheter and DepotKXK · Traditional | Colab Intl., Inc. | 07/11/1990SE |
| K852023 | Cesium 137 Source, CSM-4, CSM-11, CSM-41KXK · Traditional | Syncor Intl. Corp. | 08/21/1985SE |
| K850433 | Cesium 137 Endometrial SourceKXK · Traditional | Syncor Intl. Corp. | 08/21/1985SE |
| K850434 | CS137 Sealed SourcesKXK · Traditional | Syncor Intl. Corp. | 03/26/1985SE |
| K801748 | 3M I-125 Seeds in Absorbable CarrierKXK · Traditional | 3M Company | 12/18/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1702-2018 Class II | BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule…Bard Medical Division is recalling the BARD BrachySource Iodine125 Radioactive Seeds in Mick Applicators and… | Bard Brachytherapy, Inc. | 04/10/2018Terminated |
| Z-0267-2018 Class II | I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in…Activity and quantity of seeds sent in shipments were incorrect. | C.R. Bard, Inc. | 12/09/2016Terminated |
| Z-1385-2012 | VariSeed 7.1, software application, part number H62, manufactured by Varian Medical…Brachytherapy device requires the user to enter radioactive source activity, but software may specify… | Varian Medical Systems, Inc. | 01/25/2012Terminated |
| Z-0266-2012 | Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding…There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient… | Medi-Physics Inc. dba GE Healthcare | 09/20/2011Terminated |
| Z-1717-2009 | M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy…Radioactive source broke during use. | Source Production & Equipment Inc | 03/03/2008Terminated |