FDA Product Code
FDA Product Code KXK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5730
510(k) Clearances — 151 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252296 | OncoPatch | Oncopatch, Inc. | 2025-12-05 | Traditional | PDF ↗ |
| K242818 | IsoSphere | Isoaid, LLC | 2025-07-15 | Traditional | PDF ↗ |
| K223465 | RadianceTx Radionuclide Brachytherapy Source | Radiance Therapeutics, Inc. | 2023-01-11 | Traditional | PDF ↗ |
| K221539 | GammaTile | Gt Medical Technologies | 2022-11-09 | Traditional | PDF ↗ |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles | Isoray Medical, Inc. | 2020-12-31 | Traditional | PDF ↗ |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | Lv Liberty Vision Corporation | 2020-05-29 | Special | PDF ↗ |
| K190839 | GammaTile | Gt Medical Technologies | 2020-01-23 | Traditional | PDF ↗ |
| K191324 | CivaDerm | Civatech Oncology, Inc. | 2019-09-20 | Traditional | PDF ↗ |
| K190296 | GammaTile | Gt Medical Technologies | 2019-03-13 | Special | PDF ↗ |
| K180515 | GammaTile | Isoray Medical, Inc. | 2018-07-06 | Traditional | PDF ↗ |
| K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017-08-25 | Traditional | PDF ↗ |
| K163572 | LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source | Lv Liberty Vision Corp. | 2017-03-15 | Traditional | PDF ↗ |
| K163206 | SMD-Sr90-DA Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | 2016-12-15 | Traditional | PDF ↗ |
| K162573 | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source | Source Production and Equipment Co., Inc. | 2016-11-04 | Traditional | PDF ↗ |
| K161396 | SPEC Model M23 | Source Production and Equipment Co., Inc. | 2016-08-17 | Traditional | PDF ↗ |
| K161395 | SPEC Model M13 | Source Production and Equipment Co., Inc. | 2016-07-06 | Traditional | PDF ↗ |
| K150895 | SPEC Model M16 | Source Production and Equipment Co., Inc. | 2015-06-19 | Traditional | PDF ↗ |
| K150636 | VariSeed 9.0 | Varian Medical Systems, Inc. | 2015-05-08 | Traditional | PDF ↗ |
| K142701 | SMD Sr90-1 Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | 2014-12-19 | Traditional | PDF ↗ |
| K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | Isoaid, LLC | 2014-12-05 | Traditional | PDF ↗ |
| K142668 | Lesion-Loc Iodine I-125 Seed/Needle | Intramedical Imaging, LLC | 2014-11-21 | Traditional | PDF ↗ |
| K141038 | ANT MODEL 1 | Advanced Nuclide Technologies, LLC | 2014-11-12 | Traditional | PDF ↗ |
| K140490 | CIVA SHEET PD-103 | Civatech Oncology, Inc. | 2014-08-29 | Traditional | PDF ↗ |
| K140849 | ISOSEED | Eckert & Ziegler Bebig GmbH | 2014-07-02 | Abbreviated | PDF ↗ |
| K140856 | BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS | C.R. Bard, Inc. | 2014-05-02 | Special | PDF ↗ |
| K132969 | SPEC MODEL M15 | Source Production & Equipment Co., Inc. | 2014-01-02 | Traditional | PDF ↗ |
| K132996 | CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS | Isoray, Inc. | 2013-12-17 | Traditional | PDF ↗ |
| K131689 | MRI MARKER | C4 Imaging, LLC | 2013-11-20 | Traditional | PDF ↗ |
| K122704 | BEST LOCALIZATION NEEDLE WITH I-125 SEED | Best Medical Intl. | 2013-01-09 | Traditional | PDF ↗ |
| K122764 | RAPID STRAND RX | Medi-Physics, Inc. | 2012-12-28 | Traditional | PDF ↗ |
| K113210 | ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT | Isoaid, LLC | 2012-08-10 | Traditional | PDF ↗ |
| K120859 | PRE-LOADED GOLD VISICOIL CK MARKER | Radiomed Corporation | 2012-04-19 | Special | PDF ↗ |
| K111979 | RADIOACTIVE SEED LOCALIZATION NEEDLE | Biocompatibles, Inc. | 2011-10-18 | Traditional | PDF ↗ |
| K111931 | GLIASITE RTS | Isoray Medical, Inc. | 2011-08-05 | Special | PDF ↗ |
| K102811 | AOS ORION IR-192 SOURCE CABLE | Alpha-Omega Services, Inc. | 2011-06-02 | Traditional | PDF ↗ |
| K103449 | BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS | Riverpoint Medical | 2011-02-25 | Abbreviated | PDF ↗ |
| K103319 | I-SEED | Theragenics Corp. | 2011-01-03 | Abbreviated | PDF ↗ |
| K100847 | SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 | Biocompatibles, Inc. | 2010-05-21 | Traditional | PDF ↗ |
| K093663 | RADIONUCLIDE BRACHYTHERAPY SOURCE | C.R. Bard, Inc. | 2009-12-23 | Special | PDF ↗ |
| K092522 | ACU007S | Oncology Systems, Inc. | 2009-11-20 | Traditional | PDF ↗ |
| K091117 | ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA | Isoaid, LLC | 2009-09-15 | Traditional | PDF ↗ |
| K092458 | PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 | Isoray Medical, Inc. | 2009-08-28 | Special | PDF ↗ |
| K092136 | PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 | Isoray Medical, Inc. | 2009-08-07 | Special | PDF ↗ |
| K090366 | SPEC MODEL M-31 | Source Production & Equipment Co., Inc. | 2009-04-22 | Traditional | PDF ↗ |
| K083274 | WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER | Biocompatibles, Inc. | 2009-01-08 | Traditional | PDF ↗ |
| K082159 | CIVASTRING PD-103 | Civatech Oncology, Inc. | 2008-09-30 | Traditional | PDF ↗ |
| K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 | Theragenics Corp. | 2007-09-26 | Abbreviated | PDF ↗ |
| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | Cp Medical | 2007-07-18 | Abbreviated | PDF ↗ |
| K062825 | AOS MARKER SEEDS | Alpha-Omega Services, Inc. | 2007-05-22 | Traditional | PDF ↗ |
| K070468 | IMPLANT SCIENCES CORP. MODEL HDR 4454 | Implant Sciences Corp. | 2007-03-23 | Special | PDF ↗ |
| K062214 | BRACHYSCIENCES STRANDPORT | Worldwide Medical Technologies, LLC | 2007-03-01 | Traditional | PDF ↗ |
| K063177 | RAPID STRAND RX | Oncura, Inc. | 2006-11-30 | Traditional | PDF ↗ |
| K062384 | CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE | Isoray, Inc. | 2006-11-09 | Special | PDF ↗ |
| K061638 | BEST STRAND AND BEST SPACER | Best Medical International, Inc. | 2006-08-04 | Traditional | PDF ↗ |
| K060679 | SURTRAK IMPLANTATION KIT | North American Scientific, Inc. | 2006-04-21 | Traditional | PDF ↗ |
| K060636 | PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE | C.R. Bard, Inc. | 2006-04-19 | Traditional | PDF ↗ |
| K053595 | CURAY CUSTOM SEED ARRAY | Biolucent, Inc. | 2006-02-28 | Traditional | PDF ↗ |
| K052024 | NSTRAND IMPLANTATION KIT | North American Scientific, Inc. | 2005-09-07 | Traditional | PDF ↗ |
| K043246 | BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS | C.R. Bard, Inc. | 2005-02-02 | Traditional | PDF ↗ |
| K043596 | THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 | Theragenics Corp. | 2005-01-26 | Special | PDF ↗ |
| K043336 | OPTISTRAND, MODEL 1032S | Ibt SA | 2005-01-21 | Traditional | PDF ↗ |
| K042864 | IMPLANT SCIENCES CORP, MODEL HDR-4140 | Implant Sciences Corp. | 2005-01-06 | Traditional | PDF ↗ |
| K043117 | BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER | Best Medical International, Inc. | 2004-12-09 | Traditional | PDF ↗ |
| K042786 | BEST MODEL # 81-01 SERIES IR-192 SOURCES | Best Medical International, Inc. | 2004-11-18 | Abbreviated | PDF ↗ |
| K040766 | OPTISOURCE, MODEL 1032P | International Brachytherapy S.A. | 2004-07-22 | Traditional | PDF ↗ |
| K041702 | EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) | Ibt SA | 2004-07-16 | Special | PDF ↗ |
| K041576 | SOURCELINK | C.R. Bard, Inc. | 2004-07-02 | Special | PDF ↗ |
| K040339 | BRACHYTHERAPY STRAND DEVICE | Bebig Isotopen-Und Medizintechnik GmbH | 2004-04-08 | Traditional | PDF ↗ |
| K033770 | ISOAID ADVANTAGE PD-103, MODEL IAPD-103A | Isoaid, LLC | 2004-04-08 | Traditional | PDF ↗ |
| K034062 | CP SLEEVE AND RIVER SLEEVE | Cp Medical | 2004-01-30 | Special | PDF ↗ |
| K033781 | BEBIG ISOSEED I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2003-12-30 | Special | PDF ↗ |
| K023179 | READI-STRAND, MODEL PSSTRAND | Worldwide Medical Technologies, LLC | 2003-07-02 | Traditional | PDF ↗ |
| K021360 | SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 | Med-Tec,Inc. | 2003-06-10 | Traditional | PDF ↗ |
| K022705 | READI-STRAND, MODEL PSSTRAND | Worldwide Medical Technologies, LLC | 2003-06-09 | Traditional | PDF ↗ |
| K030534 | VARISEED 7.1 | Varian Medical Systems | 2003-05-21 | Traditional | PDF ↗ |
| K022389 | READI-LOAD SYSTEM, MODEL PSS 1820RL | Worldwide Medical Technologies, LLC | 2003-05-06 | Traditional | PDF ↗ |
| K030594 | I-125 RAPID STRAND, MODEL 7000 | Amersham Health | 2003-04-10 | Special | PDF ↗ |
| K023073 | SEED LINK | Implant Sciences Corp. | 2003-04-07 | Traditional | PDF ↗ |
| K030162 | LAWRENCE CSERION, MODEL CS-1 | Isoray, Inc. | 2003-03-28 | Abbreviated | PDF ↗ |
| K023210 | SEEDLINKS, MODELS 70301, 70302, 70303 | Sourcetech Medical, LLC | 2003-03-28 | Traditional | PDF ↗ |
| K024183 | ALTON PT STEPPER | Alton Design, LLC | 2003-03-17 | Traditional | PDF ↗ |
| K030745 | GAMMAMED 212 AND 232 SOURCE ASSEMBLY | Varian Medical Systems | 2003-03-12 | Traditional | PDF ↗ |
| K010705 | OPTIDOS | Ptw-New York Corp. | 2003-03-11 | Traditional | PDF ↗ |
| K020683 | ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 | Ati Medical, Inc. | 2002-12-17 | Traditional | PDF ↗ |
| K023242 | I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE | Implant Sciences Corp. | 2002-12-04 | Special | PDF ↗ |
| K020337 | READI-STRAND; MODEL PSSTRAND | Worldwide Medical Technologies, LLC | 2002-07-29 | Traditional | PDF ↗ |
| K021311 | SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL | Cp Medical | 2002-07-13 | Traditional | PDF ↗ |
| K021343 | ISOSEEDS I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2002-05-20 | Traditional | PDF ↗ |
| K013975 | CP-SLEEVE | Cp Medical | 2002-02-22 | Traditional | PDF ↗ |
| K013964 | MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS | Cp Medical | 2002-01-24 | Special | PDF ↗ |
| K013660 | GENETRA | Radiomed Corporation | 2001-12-05 | Special | PDF ↗ |
| K010621 | ACCU-SPACE ABSORBABLE SEEDING SPACERS | Cp Medical | 2001-09-04 | Traditional | PDF ↗ |
| K011427 | MBI PD-103 SL; MBI PD-103 SH | Mills Biopharmaceuticals, Inc. | 2001-08-31 | Traditional | PDF ↗ |
| K011155 | INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S | Ibt, Inc. | 2001-07-12 | Abbreviated | PDF ↗ |
| K011205 | ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 | Isoaid | 2001-07-10 | Traditional | PDF ↗ |
| K011119 | BRACHYSEED PD-103 MODELS #PD1 | Draximage, Inc. | 2001-06-25 | Abbreviated | PDF ↗ |
| K010283 | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 | Theragenics Corp. | 2001-04-26 | Traditional | PDF ↗ |
| K003206 | GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 | Proxima Therapeutics, Inc. | 2001-04-25 | Traditional | PDF ↗ |
| K010821 | ECHOSEED/IODINE-125 SEEDS, MODEL 6733 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 2001-04-11 | Special | PDF ↗ |
| K002429 | SELECT SEED I-125 | Nucletron Corp. | 2001-02-02 | Traditional | PDF ↗ |
Product code KXK · Class II · Radiology. Data: openFDA.