Product Code: KXK FDA class 2 21 CFR 892.5730

Source, Brachytherapy, Radionuclide

Radiology

The Radionuclide Brachytherapy Source is a radiation-emitting device implanted at or near a tumor site to deliver targeted radiation therapy for the treatment of cancer, using radioactive isotopes encapsulated within seeds, wires, or other delivery formats. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KXK, regulated under 21 CFR 892.5730, in the Radiology medical specialty. This device is an implant.

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510(k)s

151

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KXK
Device Class: FDA class 2
Regulation Number: 892.5730
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 151 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252296	OncoPatch	Dec 05, 2025	Substantially Equivalent	Oncopatch, Inc.
K242818	IsoSphere	Jul 15, 2025	Substantially Equivalent	Isoaid, LLC
K223465	RadianceTx Radionuclide Brachytherapy Source	Jan 11, 2023	Substantially Equivalent	Radiance Therapeutics, Inc.
K221539	GammaTile	Nov 09, 2022	Substantially Equivalent	Gt Medical Technologies
K202267	Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles	Dec 31, 2020	Substantially Equivalent	Isoray Medical, Inc.
K193602	LV Liberty Vision Model 1 90Yttrium Brachytherapy Source	May 29, 2020	Substantially Equivalent	Lv Liberty Vision Corporation
K190839	GammaTile	Jan 23, 2020	Substantially Equivalent	Gt Medical Technologies
K191324	CivaDerm	Sep 20, 2019	Substantially Equivalent	Civatech Oncology, Inc.
K190296	GammaTile	Mar 13, 2019	Substantially Equivalent	Gt Medical Technologies
K180515	GammaTile	Jul 06, 2018	Substantially Equivalent	Isoray Medical, Inc.
K171487	Sirius MRI Marker NS	Aug 25, 2017	Substantially Equivalent	C4 Imaging, LLC
K163572	LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source	Mar 15, 2017	Substantially Equivalent	Lv Liberty Vision Corp.
K163206	SMD-Sr90-DA Radionuclide Brachytherapy Source	Dec 15, 2016	Substantially Equivalent	Salutaris Medical Devices, Inc.
K162573	Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source	Nov 04, 2016	Substantially Equivalent	Source Production and Equipment Co., Inc.
K161396	SPEC Model M23	Aug 17, 2016	Substantially Equivalent	Source Production and Equipment Co., Inc.
K161395	SPEC Model M13	Jul 06, 2016	Substantially Equivalent	Source Production and Equipment Co., Inc.
K150895	SPEC Model M16	Jun 19, 2015	Substantially Equivalent	Source Production and Equipment Co., Inc.
K150636	VariSeed 9.0	May 08, 2015	Substantially Equivalent	Varian Medical Systems, Inc.
K142701	SMD Sr90-1 Radionuclide Brachytherapy Source	Dec 19, 2014	Substantially Equivalent	Salutaris Medical Devices, Inc.
K141701	I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]	Dec 05, 2014	Substantially Equivalent	Isoaid, LLC
K142668	Lesion-Loc Iodine I-125 Seed/Needle	Nov 21, 2014	Substantially Equivalent	Intramedical Imaging, LLC
K141038	ANT MODEL 1	Nov 12, 2014	Substantially Equivalent	Advanced Nuclide Technologies, LLC
K140490	CIVA SHEET PD-103	Aug 29, 2014	Substantially Equivalent	Civatech Oncology, Inc.
K140849	ISOSEED	Jul 02, 2014	Substantially Equivalent	Eckert & Ziegler Bebig GmbH
K140856	BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS	May 02, 2014	Substantially Equivalent	C.R. Bard, Inc.
K132969	SPEC MODEL M15	Jan 02, 2014	Substantially Equivalent	Source Production & Equipment Co., Inc.
K132996	CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS	Dec 17, 2013	Substantially Equivalent	Isoray, Inc.
K131689	MRI MARKER	Nov 20, 2013	Substantially Equivalent	C4 Imaging, LLC
K122704	BEST LOCALIZATION NEEDLE WITH I-125 SEED	Jan 09, 2013	Substantially Equivalent	Best Medical Intl.
K122764	RAPID STRAND RX	Dec 28, 2012	Substantially Equivalent	Medi-Physics, Inc.
K113210	ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT	Aug 10, 2012	Substantially Equivalent	Isoaid, LLC
K120859	PRE-LOADED GOLD VISICOIL CK MARKER	Apr 19, 2012	Substantially Equivalent	Radiomed Corporation
K111979	RADIOACTIVE SEED LOCALIZATION NEEDLE	Oct 18, 2011	Substantially Equivalent	Biocompatibles, Inc.
K111931	GLIASITE RTS	Aug 05, 2011	Substantially Equivalent	Isoray Medical, Inc.
K102811	AOS ORION IR-192 SOURCE CABLE	Jun 02, 2011	Substantially Equivalent	Alpha-Omega Services, Inc.
K103449	BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS	Feb 25, 2011	Substantially Equivalent	Riverpoint Medical
K103319	I-SEED	Jan 03, 2011	Substantially Equivalent	Theragenics Corp.
K100847	SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30	May 21, 2010	Substantially Equivalent	Biocompatibles, Inc.
K093663	RADIONUCLIDE BRACHYTHERAPY SOURCE	Dec 23, 2009	Substantially Equivalent	C.R. Bard, Inc.
K092522	ACU007S	Nov 20, 2009	Substantially Equivalent	Oncology Systems, Inc.
K091117	ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA	Sep 15, 2009	Substantially Equivalent	Isoaid, LLC
K092458	PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2	Aug 28, 2009	Substantially Equivalent	Isoray Medical, Inc.
K092136	PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5	Aug 07, 2009	Substantially Equivalent	Isoray Medical, Inc.
K090366	SPEC MODEL M-31	Apr 22, 2009	Substantially Equivalent	Source Production & Equipment Co., Inc.
K083274	WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER	Jan 08, 2009	Substantially Equivalent	Biocompatibles, Inc.
K082159	CIVASTRING PD-103	Sep 30, 2008	Substantially Equivalent	Civatech Oncology, Inc.
K072296	POIINT OF CARE STRANDING SYSTEM, MODE 1004-00	Sep 26, 2007	Substantially Equivalent	Theragenics Corp.
K071550	PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS	Jul 18, 2007	Substantially Equivalent	Cp Medical
K062825	AOS MARKER SEEDS	May 22, 2007	Substantially Equivalent	Alpha-Omega Services, Inc.
K070468	IMPLANT SCIENCES CORP. MODEL HDR 4454	Mar 23, 2007	Substantially Equivalent	Implant Sciences Corp.
K062214	BRACHYSCIENCES STRANDPORT	Mar 01, 2007	Substantially Equivalent	Worldwide Medical Technologies, LLC
K063177	RAPID STRAND RX	Nov 30, 2006	Substantially Equivalent	Oncura, Inc.
K062384	CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE	Nov 09, 2006	Substantially Equivalent	Isoray, Inc.
K061638	BEST STRAND AND BEST SPACER	Aug 04, 2006	Substantially Equivalent	Best Medical International, Inc.
K060679	SURTRAK IMPLANTATION KIT	Apr 21, 2006	Substantially Equivalent	North American Scientific, Inc.
K060636	PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE	Apr 19, 2006	Substantially Equivalent	C.R. Bard, Inc.
K053595	CURAY CUSTOM SEED ARRAY	Feb 28, 2006	Substantially Equivalent	Biolucent, Inc.
K052024	NSTRAND IMPLANTATION KIT	Sep 07, 2005	Substantially Equivalent	North American Scientific, Inc.
K043246	BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS	Feb 02, 2005	Substantially Equivalent	C.R. Bard, Inc.
K043596	THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06	Jan 26, 2005	Substantially Equivalent	Theragenics Corp.
K043336	OPTISTRAND, MODEL 1032S	Jan 21, 2005	Substantially Equivalent	Ibt SA
K042864	IMPLANT SCIENCES CORP, MODEL HDR-4140	Jan 06, 2005	Substantially Equivalent	Implant Sciences Corp.
K043117	BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER	Dec 09, 2004	Substantially Equivalent	Best Medical International, Inc.
K042786	BEST MODEL # 81-01 SERIES IR-192 SOURCES	Nov 18, 2004	Substantially Equivalent	Best Medical International, Inc.
K040766	OPTISOURCE, MODEL 1032P	Jul 22, 2004	Substantially Equivalent	International Brachytherapy S.A.
K041702	EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)	Jul 16, 2004	Substantially Equivalent	Ibt SA
K041576	SOURCELINK	Jul 02, 2004	Substantially Equivalent	C.R. Bard, Inc.
K040339	BRACHYTHERAPY STRAND DEVICE	Apr 08, 2004	Substantially Equivalent	Bebig Isotopen-Und Medizintechnik GmbH
K033770	ISOAID ADVANTAGE PD-103, MODEL IAPD-103A	Apr 08, 2004	Substantially Equivalent	Isoaid, LLC
K034062	CP SLEEVE AND RIVER SLEEVE	Jan 30, 2004	Substantially Equivalent	Cp Medical
K033781	BEBIG ISOSEED I-125	Dec 30, 2003	Substantially Equivalent	Bebig Isotopen-Und Medizintechnik GmbH
K023179	READI-STRAND, MODEL PSSTRAND	Jul 02, 2003	Substantially Equivalent	Worldwide Medical Technologies, LLC
K021360	SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000	Jun 10, 2003	Substantially Equivalent	Med-Tec,Inc.
K022705	READI-STRAND, MODEL PSSTRAND	Jun 09, 2003	Substantially Equivalent	Worldwide Medical Technologies, LLC
K030534	VARISEED 7.1	May 21, 2003	Substantially Equivalent	Varian Medical Systems
K022389	READI-LOAD SYSTEM, MODEL PSS 1820RL	May 06, 2003	Substantially Equivalent	Worldwide Medical Technologies, LLC
K030594	I-125 RAPID STRAND, MODEL 7000	Apr 10, 2003	Substantially Equivalent	Amersham Health
K023073	SEED LINK	Apr 07, 2003	Substantially Equivalent	Implant Sciences Corp.
K030162	LAWRENCE CSERION, MODEL CS-1	Mar 28, 2003	Substantially Equivalent	Isoray, Inc.
K023210	SEEDLINKS, MODELS 70301, 70302, 70303	Mar 28, 2003	Substantially Equivalent	Sourcetech Medical, LLC
K024183	ALTON PT STEPPER	Mar 17, 2003	Substantially Equivalent	Alton Design, LLC
K030745	GAMMAMED 212 AND 232 SOURCE ASSEMBLY	Mar 12, 2003	Substantially Equivalent	Varian Medical Systems
K010705	OPTIDOS	Mar 11, 2003	Substantially Equivalent	Ptw-New York Corp.
K020683	ISOROD PD-103 IMPLANT, MODEL ATI-PD-103	Dec 17, 2002	Substantially Equivalent	Ati Medical, Inc.
K023242	I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE	Dec 04, 2002	Substantially Equivalent	Implant Sciences Corp.
K020337	READI-STRAND; MODEL PSSTRAND	Jul 29, 2002	Substantially Equivalent	Worldwide Medical Technologies, LLC
K021311	SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL	Jul 13, 2002	Substantially Equivalent	Cp Medical
K021343	ISOSEEDS I-125	May 20, 2002	Substantially Equivalent	Bebig Isotopen-Und Medizintechnik GmbH
K013975	CP-SLEEVE	Feb 22, 2002	Substantially Equivalent	Cp Medical
K013964	MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS	Jan 24, 2002	Substantially Equivalent	Cp Medical
K013660	GENETRA	Dec 05, 2001	Substantially Equivalent	Radiomed Corporation
K010621	ACCU-SPACE ABSORBABLE SEEDING SPACERS	Sep 04, 2001	Substantially Equivalent	Cp Medical
K011427	MBI PD-103 SL; MBI PD-103 SH	Aug 31, 2001	Substantially Equivalent	Mills Biopharmaceuticals, Inc.
K011155	INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S	Jul 12, 2001	Substantially Equivalent	Ibt, Inc.
K011205	ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125	Jul 10, 2001	Substantially Equivalent	Isoaid
K011119	BRACHYSEED PD-103 MODELS #PD1	Jun 25, 2001	Substantially Equivalent	Draximage, Inc.
K010283	THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200	Apr 26, 2001	Substantially Equivalent	Theragenics Corp.
K003206	GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005	Apr 25, 2001	Substantially Equivalent	Proxima Therapeutics, Inc.
K010821	ECHOSEED/IODINE-125 SEEDS, MODEL 6733	Apr 11, 2001	Substantially Equivalent	Medi-Physics Inc. Dba Nycomed Amersham Imaging
K002429	SELECT SEED I-125	Feb 02, 2001	Substantially Equivalent	Nucletron Corp.
K001070	RADIOMED SOURCE	Oct 24, 2000	Substantially Equivalent	Radiomed Corp.
K002446	RE-ENTRANT CHAMBER, MODEL 1008 OR 44D	Oct 23, 2000	Substantially Equivalent	Sun Nuclear Corp.
K001366	PROSTEC 125I BRANCHYTHERAPY SNAPSEED	Sep 19, 2000	Substantially Equivalent	Prostec, LLC
K001765	LOOK COLLAGEN SPACERS, MODEL 1514B	Sep 07, 2000	Substantially Equivalent	Surgical Specialties Corp
K000475	BRACHYSEED	Aug 22, 2000	Substantially Equivalent	Draximage, Inc.
K994018	PHARMASEED, MODEL BT-125-3	Jul 17, 2000	Substantially Equivalent	Syncor Pharmaceuticals, Inc.
K994016	PHARMASEED, MODEL BT-103-3	Jul 14, 2000	Substantially Equivalent	Syncor Pharmaceuticals, Inc.
K993701	PHARMASEED, MODEL BT-125-2	Jun 09, 2000	Substantially Equivalent	Syncor International, Inc.
K993700	PHARMASEED, MODEL BT-103-2	Jun 02, 2000	Substantially Equivalent	Syncor International, Inc.
K993552	ISOSEED PD-103	Mar 31, 2000	Substantially Equivalent	Bebig Isotopentechnik GmbH
K994317	I-PLANT, MODEL 3500	Mar 21, 2000	Substantially Equivalent	Implant Sciences Corp.
K991881	125-IMPLANT SEEDS, MODEL STM1250	Mar 16, 2000	Substantially Equivalent	Sourcetech Medical, LLC
K993280	PROSTEC 125I BRACHYTHERAPY SEEDS	Mar 14, 2000	Substantially Equivalent	Prostec, LLC
K991571	10 CURIE IRDIUM 192, CSN00100-192	Feb 22, 2000	Substantially Equivalent	Alpha-Omega Services, Inc.
K992007	PHARMASEED, MODEL BT-103-1	Jan 14, 2000	Substantially Equivalent	Syncor Pharmaceuticals, Inc.
K992008	PHARMASEED, MODEL BT-125-1	Dec 23, 1999	Substantially Equivalent	Syncor Pharmaceuticals, Inc.
K991344	WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS	Nov 05, 1999	Substantially Equivalent	Worldwide Medical Technologies, LLC
K991280	125 IMPLANT SEEDS, MODEL STM1251	Oct 20, 1999	Substantially Equivalent	Sourcetech Medical, LLC
K992262	INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM	Oct 04, 1999	Substantially Equivalent	Indigo Medical, Inc.
K992963	I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401	Sep 21, 1999	Substantially Equivalent	International Isotopes, Inc.
K991526	ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501	Jun 17, 1999	Substantially Equivalent	Imagyn Medical Technologies, Inc.
K984235	INTERSOURCE 125, MODEL 1251L	Jun 09, 1999	Substantially Equivalent	International Brachytherapy, Inc.
K990193	IODINE BRACHYTHERAPY SEEDS, MODEL 3000	May 20, 1999	Substantially Equivalent	Implant Sciences Corp.
K982226	UROMED BRACHYTHERAPHY IODINE-125 SOURCES	May 13, 1999	Substantially Equivalent	Uromed Corp.
K984446	`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH	Apr 16, 1999	Substantially Equivalent	Urocor, Inc.
K973328	INTERSOURCE	Dec 10, 1998	Substantially Equivalent	International Brachytherapy S.A.
K972271	NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A	Oct 28, 1997	Substantially Equivalent	Ml Strategies, Inc.
K964647	NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE	Feb 10, 1997	Substantially Equivalent	North American Scientific, Inc.
K945983	BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS	Oct 18, 1995	Substantially Equivalent	Bebig Trade, Inc.
K936086	STERILE VIDEO CAMERA COVER AND DRAPE	Mar 17, 1994	Substantially Equivalent	Micromedical Devices, Inc.
K931393	BEBIG PLAQUES RUM101-RUM114	Mar 16, 1994	Substantially Equivalent	Bebig, Inc.
K923697	RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U	Dec 13, 1993	Substantially Equivalent	Radionics, Inc.
K932242	RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345	Jul 27, 1993	Substantially Equivalent	Best Industries
K930570	RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES	Jun 04, 1993	Substantially Equivalent	Best Industries
K924261	RADIOACTIVE CESIUM-131 SEEDS/SOURCES	Jun 04, 1993	Substantially Equivalent	Best Industries
K920880	BRAINSCAN BRACHYTHERAPY MODULE	Dec 30, 1992	Substantially Equivalent	Brainlab
K923130	IR-192 IMPLANT -- MODIFICATION	Sep 21, 1992	Substantially Equivalent	Omnitron Intl., Inc.
K914825	1-125 ENDOSEED	Mar 19, 1992	Substantially Equivalent	Endo Technic Corp.
K915156	I-125 SEEDS CODE: 6702	Jan 06, 1992	Substantially Equivalent	Medi-Physics Inc. Dba Nycomed Amersham Imaging
K914281	I-125 SEEDS, CODE: 6711	Nov 22, 1991	Substantially Equivalent	Medi-Physics Inc. Dba Nycomed Amersham Imaging
K914268	I-125 SEEDS IN CARRIER, CODE: 6720	Nov 22, 1991	Substantially Equivalent	Medi-Physics Inc. Dba Nycomed Amersham Imaging
K910710	RADIOACTIVE SEEDS	Jun 10, 1991	Substantially Equivalent	Best Assoc. Corp.
K911775	OMNICATH IMPLANTED CATHETER AND DEPOT	May 08, 1991	Substantially Equivalent	Omnitron Intl., Inc.
K902488	MODIFIED CASS SYSTEM	Dec 07, 1990	Substantially Equivalent	Medical Instrumentation & Diagnostics Corp.(Midco)
K903465	IR-192 IMPLANT	Oct 12, 1990	Substantially Equivalent	Rads S.L., Inc.
K902622	MANAN PROSTATE SEEDING NEEDLE	Aug 10, 1990	Substantially Equivalent	Manan Medical Products, Inc.
K896197	COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT	Jul 11, 1990	Substantially Equivalent	Colab Intl., Inc.
K852023	CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41	Aug 21, 1985	Substantially Equivalent	Syncor Intl. Corp.
K850433	CESIUM 137 ENDOMETRIAL SOURCE	Aug 21, 1985	Substantially Equivalent	Syncor Intl. Corp.
K850434	CS137 SEALED SOURCES	Mar 26, 1985	Substantially Equivalent	Syncor Intl. Corp.
K801748	3M I-125 SEEDS IN ABSORBABLE CARRIER	Dec 18, 1980	Substantially Equivalent	3M Company