FDA 510(k) Applications for Medical Device Product Code "KXK"
(Source, Brachytherapy, Radionuclide)

FDA 510(k) Number Applicant Device Name Decision Date
K141038 ADVANCED NUCLIDE TECHNOLOGIES, LLC ANT MODEL 1 11/12/2014
K991571 ALPHA-OMEGA SERVICES, INC. 10 CURIE IRDIUM 192, CSN00100-192 02/22/2000
K062825 ALPHA-OMEGA SERVICES, INC. AOS MARKER SEEDS 05/22/2007
K102811 ALPHA-OMEGA SERVICES, INC. AOS ORION IR-192 SOURCE CABLE 06/02/2011
K024183 ALTON DESIGN, LLC ALTON PT STEPPER 03/17/2003
K030594 AMERSHAM HEALTH I-125 RAPID STRAND, MODEL 7000 04/10/2003
K020683 ATI MEDICAL, INC. ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 12/17/2002
K033781 BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH BEBIG ISOSEED I-125 12/30/2003
K040339 BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH BRACHYTHERAPY STRAND DEVICE 04/08/2004
K021343 BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH ISOSEEDS I-125 05/20/2002
K993552 BEBIG ISOTOPENTECHNIK GMBH ISOSEED PD-103 03/31/2000
K042786 BEST MEDICAL INTERNATIONAL, INC. BEST MODEL # 81-01 SERIES IR-192 SOURCES 11/18/2004
K043117 BEST MEDICAL INTERNATIONAL, INC. BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER 12/09/2004
K061638 BEST MEDICAL INTERNATIONAL, INC. BEST STRAND AND BEST SPACER 08/04/2006
K122704 BEST MEDICAL INTL. BEST LOCALIZATION NEEDLE WITH I-125 SEED 01/09/2013
K111979 BIOCOMPATIBLES INC. RADIOACTIVE SEED LOCALIZATION NEEDLE 10/18/2011
K100847 BIOCOMPATIBLES, INC. SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 05/21/2010
K083274 BIOCOMPATIBLES, INC. WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER 01/08/2009
K053595 BIOLUCENT, INC. CURAY CUSTOM SEED ARRAY 02/28/2006
K043246 C.R. BARD, INC. BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS 02/02/2005
K140856 C.R. BARD, INC. BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS 05/02/2014
K060636 C.R. BARD, INC. PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE 04/19/2006
K093663 C.R. BARD, INC. RADIONUCLIDE BRACHYTHERAPY SOURCE 12/23/2009
K041576 C.R. BARD, INC. SOURCELINK 07/02/2004
K131689 C4 IMAGING LLC MRI MARKER 11/20/2013
K171487 C4 Imaging, LLC Sirius MRI Marker NS 08/25/2017
K191324 CivaTech Oncology Inc. CivaDerm 09/20/2019
K140490 CIVATECH ONCOLOGY, INC. CIVA SHEET PD-103 08/29/2014
K082159 CIVATECH ONCOLOGY, INC. CIVASTRING PD-103 09/30/2008
K010621 CP MEDICAL ACCU-SPACE ABSORBABLE SEEDING SPACERS 09/04/2001
K034062 CP MEDICAL CP SLEEVE AND RIVER SLEEVE 01/30/2004
K013975 CP MEDICAL CP-SLEEVE 02/22/2002
K013964 CP MEDICAL MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS 01/24/2002
K071550 CP MEDICAL PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS 07/18/2007
K021311 CP MEDICAL SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL 07/13/2002
K000475 DRAXIMAGE, INC. BRACHYSEED 08/22/2000
K011119 DRAXIMAGE, INC. BRACHYSEED PD-103 MODELS #PD1 06/25/2001
K140849 ECKERT & ZIEGLER BEBIG GMBH ISOSEED 07/02/2014
K190296 GT Medical Technologies GammaTile 03/13/2019
K221539 GT Medical Technologies GammaTile 11/09/2022
K190839 GT Medical Technologies GammaTile 01/23/2020
K041702 IBT SA EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) 07/16/2004
K043336 IBT SA OPTISTRAND, MODEL 1032S 01/21/2005
K011155 IBT, INC. INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S 07/12/2001
K991526 IMAGYN MEDICAL TECHNOLOGIES, INC. ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 06/17/1999
K023242 IMPLANT SCIENCES CORP. I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE 12/04/2002
K994317 IMPLANT SCIENCES CORP. I-PLANT, MODEL 3500 03/21/2000
K042864 IMPLANT SCIENCES CORP. IMPLANT SCIENCES CORP, MODEL HDR-4140 01/06/2005
K070468 IMPLANT SCIENCES CORP. IMPLANT SCIENCES CORP. MODEL HDR 4454 03/23/2007
K990193 IMPLANT SCIENCES CORP. IODINE BRACHYTHERAPY SEEDS, MODEL 3000 05/20/1999
K023073 IMPLANT SCIENCES CORP. SEED LINK 04/07/2003
K992262 INDIGO MEDICAL, INC. INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM 10/04/1999
K040766 INTERNATIONAL BRACHYTHERAPY S.A. OPTISOURCE, MODEL 1032P 07/22/2004
K984235 INTERNATIONAL BRACHYTHERAPY, INC. INTERSOURCE 125, MODEL 1251L 06/09/1999
K973328 INTERNATIONAL BRACHYTHERAPY, SA INTERSOURCE 12/10/1998
K992963 INTERNATIONAL ISOTOPES, INC. I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 09/21/1999
K142668 Intramedical Imaging, LLC Lesion-Loc Iodine I-125 Seed/Needle 11/21/2014
K011205 ISOAID ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 07/10/2001
K091117 ISOAID, L.L.C. ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA 09/15/2009
K113210 ISOAID, L.L.C. ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT 08/10/2012
K141701 ISOAID, L.L.C. I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] 12/05/2014
K033770 ISOAID, L.L.C. ISOAID ADVANTAGE PD-103, MODEL IAPD-103A 04/08/2004
K180515 Isoray Medical Inc. GammaTile 07/06/2018
K111931 ISORAY MEDICAL, INC. GLIASITE RTS 08/05/2011
K092136 ISORAY MEDICAL, INC. PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 08/07/2009
K092458 ISORAY MEDICAL, INC. PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 08/28/2009
K202267 Isoray Medical, Inc. Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles 12/31/2020
K132996 ISORAY, INC CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS 12/17/2013
K062384 ISORAY, INC CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE 11/09/2006
K030162 ISORAY, INC LAWRENCE CSERION, MODEL CS-1 03/28/2003
K163572 LV Liberty Vision Corp. LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source 03/15/2017
K193602 LV Liberty Vision Corporation LV Liberty Vision Model 1 90Yttrium Brachytherapy Source 05/29/2020
K021360 MED-TEC,INC. SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 06/10/2003
K010821 MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING ECHOSEED/IODINE-125 SEEDS, MODEL 6733 04/11/2001
K122764 MEDI-PHYSICS, INC. RAPID STRAND RX 12/28/2012
K011427 MILLS BIOPHARMACEUTICALS, INC. MBI PD-103 SL; MBI PD-103 SH 08/31/2001
K972271 ML STRATEGIES, INC. NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A 10/28/1997
K964647 NORTH AMERICAN SCIENTIFIC, INC. NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE 02/10/1997
K052024 NORTH AMERICAN SCIENTIFIC, INC. NSTRAND IMPLANTATION KIT 09/07/2005
K060679 NORTH AMERICAN SCIENTIFIC, INC. SURTRAK IMPLANTATION KIT 04/21/2006
K002429 NUCLETRON CORP. SELECT SEED I-125 02/02/2001
K092522 ONCOLOGY SYSTEMS, INC. ACU007S 11/20/2009
K063177 ONCURA INC. RAPID STRAND RX 11/30/2006
K993280 PROSTEC LLC. PROSTEC 125I BRACHYTHERAPY SEEDS 03/14/2000
K001366 PROSTEC LLC. PROSTEC 125I BRANCHYTHERAPY SNAPSEED 09/19/2000
K003206 PROXIMA THERAPEUTICS, INC. GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 04/25/2001
K010705 PTW-NEW YORK CORP. OPTIDOS 03/11/2003
K223465 Radiance Therapeutics Inc. RadianceTx Radionuclide Brachytherapy Source 01/11/2023
K001070 RADIOMED CORP. RADIOMED SOURCE 10/24/2000
K013660 RADIOMED CORPORATION GENETRA 12/05/2001
K120859 RADIOMED CORPORATION PRE-LOADED GOLD VISICOIL CK MARKER 04/19/2012
K103449 RIVERPOINT MEDICAL BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS 02/25/2011
K142701 Salutaris Medical Devices, Inc. SMD Sr90-1 Radionuclide Brachytherapy Source 12/19/2014
K163206 Salutaris Medical Devices, Inc. SMD-Sr90-DA Radionuclide Brachytherapy Source 12/15/2016
K090366 SOURCE PRODUCTION & EQUIPMENT CO., INC. SPEC MODEL M-31 04/22/2009
K132969 SOURCE PRODUCTION & EQUIPMENT CO., INC. SPEC MODEL M15 01/02/2014
K162573 SOURCE PRODUCTION AND EQUIPMENT CO., INC. Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source 11/04/2016
K161395 Source Production and Equipment Co.,Inc. SPEC Model M13 07/06/2016
K150895 Source Production and Equipment Co.,Inc. SPEC Model M16 06/19/2015
K161396 Source Production and Equipment Co.,Inc. SPEC Model M23 08/17/2016
K991280 SOURCETECH MEDICAL, L.L.C. 125 IMPLANT SEEDS, MODEL STM1251 10/20/1999
K991881 SOURCETECH MEDICAL, L.L.C. 125-IMPLANT SEEDS, MODEL STM1250 03/16/2000
K023210 SOURCETECH MEDICAL, L.L.C. SEEDLINKS, MODELS 70301, 70302, 70303 03/28/2003
K002446 SUN NUCLEAR CORP. RE-ENTRANT CHAMBER, MODEL 1008 OR 44D 10/23/2000
K001765 SURGICAL SPECIALTIES CORP. LOOK COLLAGEN SPACERS, MODEL 1514B 09/07/2000
K993700 SYNCOR INTERNATIONAL, INC. PHARMASEED, MODEL BT-103-2 06/02/2000
K993701 SYNCOR INTERNATIONAL, INC. PHARMASEED, MODEL BT-125-2 06/09/2000
K992007 SYNCOR PHARMACEUTICALS, INC. PHARMASEED, MODEL BT-103-1 01/14/2000
K994016 SYNCOR PHARMACEUTICALS, INC. PHARMASEED, MODEL BT-103-3 07/14/2000
K992008 SYNCOR PHARMACEUTICALS, INC. PHARMASEED, MODEL BT-125-1 12/23/1999
K994018 SYNCOR PHARMACEUTICALS, INC. PHARMASEED, MODEL BT-125-3 07/17/2000
K103319 THERAGENICS CORP. I-SEED 01/03/2011
K072296 THERAGENICS CORP. POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 09/26/2007
K043596 THERAGENICS CORP. THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 01/26/2005
K010283 THERAGENICS CORP. THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 04/26/2001
K984446 UROCOR, INC. `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH 04/16/1999
K982226 UROMED CORP. UROMED BRACHYTHERAPHY IODINE-125 SOURCES 05/13/1999
K030745 VARIAN MEDICAL SYSTEMS GAMMAMED 212 AND 232 SOURCE ASSEMBLY 03/12/2003
K030534 VARIAN MEDICAL SYSTEMS VARISEED 7.1 05/21/2003
K150636 VARIAN MEDICAL SYSTEMS, INC. VariSeed 9.0 05/08/2015
K062214 WORLDWIDE MEDICAL TECHNOLOGIES, LLC BRACHYSCIENCES STRANDPORT 03/01/2007
K022389 WORLDWIDE MEDICAL TECHNOLOGIES, LLC READI-LOAD SYSTEM, MODEL PSS 1820RL 05/06/2003
K022705 WORLDWIDE MEDICAL TECHNOLOGIES, LLC READI-STRAND, MODEL PSSTRAND 06/09/2003
K023179 WORLDWIDE MEDICAL TECHNOLOGIES, LLC READI-STRAND, MODEL PSSTRAND 07/02/2003
K020337 WORLDWIDE MEDICAL TECHNOLOGIES, LLC READI-STRAND; MODEL PSSTRAND 07/29/2002
K991344 WORLDWIDE MEDICAL TECHNOLOGIES, LLC WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS 11/05/1999


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