Source, Brachytherapy, Radionuclide
Regulation 892.5730
1510(k)s in 12 months (151 all time)
0recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in KXK
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 5 | 1 |
| Cp Medical | 6 | 0 |
| Implant Sciences Corp. | 6 | 0 |
| Isoaid | 6 | 0 |
| Worldwide Medical Technologies, LLC | 6 | 0 |
| Isoray Medical, Inc. | 5 | 0 |
| Theragenics Corp. | 4 | 1 |
| Medi-Physics Inc. Dba Nycomed Amersham Imaging | 4 | 0 |
| Source Production and Equipment Co., Inc. | 4 | 0 |
| Syncor Pharmaceuticals, Inc. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2025 | K252296 | OncoPatch Oncopatch, Inc. | KXK |
| Jul 15, 2025 | K242818 | IsoSphere Isoaid, LLC | KXK |
| Jan 11, 2023 | K223465 | RadianceTx Radionuclide Brachytherapy Source Radiance Therapeutics, Inc. | KXK |
| Nov 9, 2022 | K221539 | GammaTile Gt Medical Technologies | KXK |
| Dec 31, 2020 | K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles Isoray Medical, Inc. | KXK |
| May 29, 2020 | K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source Lv Liberty Vision Corporation | KXK |
| Jan 23, 2020 | K190839 | GammaTile Gt Medical Technologies | KXK |
| Sep 20, 2019 | K191324 | CivaDerm Civatech Oncology, Inc. | KXK |
| Mar 13, 2019 | K190296 | GammaTile Gt Medical Technologies | KXK |
| Jul 6, 2018 | K180515 | GammaTile Isoray Medical, Inc. | KXK |
| Aug 25, 2017 | K171487 | Sirius MRI Marker NS C4 Imaging, LLC | KXK |
| Mar 15, 2017 | K163572 | LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source Lv Liberty Vision Corp. | KXK |
| Dec 15, 2016 | K163206 | SMD-Sr90-DA Radionuclide Brachytherapy Source Salutaris Medical Devices, Inc. | KXK |
| Nov 4, 2016 | K162573 | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source Source Production and Equipment Co., Inc. | KXK |
| Aug 17, 2016 | K161396 | SPEC Model M23 Source Production and Equipment Co., Inc. | KXK |
| Jul 6, 2016 | K161395 | SPEC Model M13 Source Production and Equipment Co., Inc. | KXK |
| Jun 19, 2015 | K150895 | SPEC Model M16 Source Production and Equipment Co., Inc. | KXK |
| May 8, 2015 | K150636 | VariSeed 9.0 Varian Medical Systems, Inc. | KXK |
| Dec 19, 2014 | K142701 | SMD Sr90-1 Radionuclide Brachytherapy Source Salutaris Medical Devices, Inc. | KXK |
| Dec 5, 2014 | K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] Isoaid, LLC | KXK |
| Nov 21, 2014 | K142668 | Lesion-Loc Iodine I-125 Seed/Needle Intramedical Imaging, LLC | KXK |
| Nov 12, 2014 | K141038 | ANT MODEL 1 Advanced Nuclide Technologies, LLC | KXK |
| Aug 29, 2014 | K140490 | CIVA SHEET PD-103 Civatech Oncology, Inc. | KXK |
| Jul 2, 2014 | K140849 | ISOSEED Eckert & Ziegler Bebig GmbH, DE | KXK |
| May 2, 2014 | K140856 | BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS C.R. Bard, Inc. | KXK |
| Jan 2, 2014 | K132969 | SPEC MODEL M15 Source Production & Equipment Co., Inc. | KXK |
| Dec 17, 2013 | K132996 | CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS Isoray, Inc. | KXK |
| Nov 20, 2013 | K131689 | MRI MARKER C4 Imaging, LLC | KXK |
| Jan 9, 2013 | K122704 | BEST LOCALIZATION NEEDLE WITH I-125 SEED Best Medical Intl. | KXK |
| Dec 28, 2012 | K122764 | RAPID STRAND RX Medi-Physics, Inc. | KXK |
| Aug 10, 2012 | K113210 | ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT Isoaid, LLC | KXK |
| Apr 19, 2012 | K120859 | PRE-LOADED GOLD VISICOIL CK MARKER Radiomed Corporation | KXK |
| Oct 18, 2011 | K111979 | RADIOACTIVE SEED LOCALIZATION NEEDLE Biocompatibles, Inc. | KXK |
| Aug 5, 2011 | K111931 | GLIASITE RTS Isoray Medical, Inc. | KXK |
| Jun 2, 2011 | K102811 | AOS ORION IR-192 SOURCE CABLE Alpha-Omega Services, Inc. | KXK |
| Feb 25, 2011 | K103449 | BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS Riverpoint Medical | KXK |
| Jan 3, 2011 | K103319 | I-SEED Theragenics Corp. | KXK |
| May 21, 2010 | K100847 | SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 Biocompatibles, Inc. | KXK |
| Dec 23, 2009 | K093663 | RADIONUCLIDE BRACHYTHERAPY SOURCE C.R. Bard, Inc. | KXK |
| Nov 20, 2009 | K092522 | ACU007S Oncology Systems, Inc. | KXK |
| Sep 15, 2009 | K091117 | ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA Isoaid, LLC | KXK |
| Aug 28, 2009 | K092458 | PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 Isoray Medical, Inc. | KXK |
| Aug 7, 2009 | K092136 | PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 Isoray Medical, Inc. | KXK |
| Apr 22, 2009 | K090366 | SPEC MODEL M-31 Source Production & Equipment Co., Inc. | KXK |
| Jan 8, 2009 | K083274 | WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER Biocompatibles, Inc. | KXK |
| Sep 30, 2008 | K082159 | CIVASTRING PD-103 Civatech Oncology, Inc. | KXK |
| Sep 26, 2007 | K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 Theragenics Corp. | KXK |
| Jul 18, 2007 | K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS Cp Medical | KXK |
| May 22, 2007 | K062825 | AOS MARKER SEEDS Alpha-Omega Services, Inc. | KXK |
| Mar 23, 2007 | K070468 | IMPLANT SCIENCES CORP. MODEL HDR 4454 Implant Sciences Corp. | KXK |
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