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 |