Source, Brachytherapy, Radionuclide

FDA product code KXK · 141 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.5730
Review panel: RA
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-12-18 – 2025-12-05

KXK 2025-12-05

OncoPatch

Applicant Oncopatch, Inc.

K number K252296

View details →

KXK 2025-07-15

IsoSphere

Applicant Isoaid, LLC

K number K242818

View details →

KXK 2023-01-11

RadianceTx Radionuclide Brachytherapy Source

Applicant Radiance Therapeutics, Inc.

K number K223465

View details →

KXK 2022-11-09

GammaTile

Applicant Gt Medical Technologies

K number K221539

View details →

KXK 2020-12-31

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles

Applicant Isoray Medical, Inc.

K number K202267

View details →

KXK 2020-05-29

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

Applicant Lv Liberty Vision Corporation

K number K193602

View details →

KXK 2020-01-23

GammaTile

Applicant Gt Medical Technologies

K number K190839

View details →

KXK 2019-09-20

CivaDerm

Applicant Civatech Oncology, Inc.

K number K191324

View details →

KXK 2019-03-13

GammaTile

Applicant Gt Medical Technologies

K number K190296

View details →

KXK 2018-07-06

GammaTile

Applicant Isoray Medical, Inc.

K number K180515

View details →

KXK 2017-08-25

Sirius MRI Marker NS

Applicant C4 Imaging, LLC

K number K171487

View details →

KXK 2017-03-15

LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source

Applicant Lv Liberty Vision Corp.

K number K163572

View details →

KXK 2016-12-15

SMD-Sr90-DA Radionuclide Brachytherapy Source

Applicant Salutaris Medical Devices, Inc.

K number K163206

View details →

KXK 2016-11-04

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source

Applicant Source Production and Equipment Co., Inc.

K number K162573

View details →

KXK 2016-08-17

SPEC Model M23

Applicant Source Production and Equipment Co., Inc.

K number K161396

View details →

KXK 2016-07-06

SPEC Model M13

Applicant Source Production and Equipment Co., Inc.

K number K161395

View details →

KXK 2013-12-17

CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS

Applicant Isoray, Inc.

K number K132996

View details →

KXK 2013-11-20

MRI MARKER

Applicant C4 Imaging, LLC

K number K131689

View details →

KXK 2013-01-09

BEST LOCALIZATION NEEDLE WITH I-125 SEED

Applicant Best Medical Intl.

K number K122704

View details →

KXK 2012-12-28

RAPID STRAND RX

Applicant Medi-Physics, Inc.

K number K122764

View details →

KXK 2012-08-10

ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT

Applicant Isoaid, LLC

K number K113210

View details →

KXK 2012-04-19

PRE-LOADED GOLD VISICOIL CK MARKER

Applicant Radiomed Corporation

K number K120859

View details →

KXK 2011-10-18

RADIOACTIVE SEED LOCALIZATION NEEDLE

Applicant Biocompatibles, Inc.

K number K111979

View details →

KXK 2011-08-05

GLIASITE RTS

Applicant Isoray Medical, Inc.

K number K111931

View details →

KXK 2011-06-02

AOS ORION IR-192 SOURCE CABLE

Applicant Alpha-Omega Services, Inc.

K number K102811

View details →

KXK 2011-02-25

BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS

Applicant Riverpoint Medical

K number K103449

View details →

KXK 2011-01-03

I-SEED

Applicant Theragenics Corp.

K number K103319

View details →

KXK 2010-05-21

SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30

Applicant Biocompatibles, Inc.

K number K100847

View details →

KXK 2009-12-23

RADIONUCLIDE BRACHYTHERAPY SOURCE

Applicant C.R. Bard, Inc.

K number K093663

View details →

KXK 2009-11-20

ACU007S

Applicant Oncology Systems, Inc.

K number K092522

View details →

KXK 2009-09-15

ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA

Applicant Isoaid, LLC

K number K091117

View details →

KXK 2009-08-28

PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2

Applicant Isoray Medical, Inc.

K number K092458

View details →

KXK 2009-08-07

PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5

Applicant Isoray Medical, Inc.

K number K092136

View details →

KXK 2009-04-22

SPEC MODEL M-31

Applicant Source Production & Equipment Co., Inc.

K number K090366

View details →

KXK 2009-01-08

WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER

Applicant Biocompatibles, Inc.

K number K083274

View details →

KXK 2008-09-30

CIVASTRING PD-103

Applicant Civatech Oncology, Inc.

K number K082159

View details →

KXK 2007-09-26

POIINT OF CARE STRANDING SYSTEM, MODE 1004-00

Applicant Theragenics Corp.

K number K072296

View details →

KXK 2007-07-18

PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS

Applicant Cp Medical

K number K071550

View details →

KXK 2007-05-22

AOS MARKER SEEDS

Applicant Alpha-Omega Services, Inc.

K number K062825

View details →

KXK 2007-03-23

IMPLANT SCIENCES CORP. MODEL HDR 4454

Applicant Implant Sciences Corp.

K number K070468

View details →

KXK 2007-03-01

BRACHYSCIENCES STRANDPORT

Applicant Worldwide Medical Technologies, LLC

K number K062214

View details →

KXK 2006-11-30

RAPID STRAND RX

Applicant Oncura, Inc.

K number K063177

View details →

KXK 2006-11-09

CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE

Applicant Isoray, Inc.

K number K062384

View details →

KXK 2006-08-04

BEST STRAND AND BEST SPACER

Applicant Best Medical International, Inc.

K number K061638

View details →

KXK 2006-04-21

SURTRAK IMPLANTATION KIT

Applicant North American Scientific, Inc.

K number K060679

View details →

KXK 2006-04-19

PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE

Applicant C.R. Bard, Inc.

K number K060636

View details →

KXK 2006-02-28

CURAY CUSTOM SEED ARRAY

Applicant Biolucent, Inc.

K number K053595

View details →

KXK 2005-09-07

NSTRAND IMPLANTATION KIT

Applicant North American Scientific, Inc.

K number K052024

View details →

KXK 2005-02-02

BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS

Applicant C.R. Bard, Inc.

K number K043246

View details →

KXK 2005-01-26

THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06

Applicant Theragenics Corp.

K number K043596

View details →

KXK 2005-01-21

OPTISTRAND, MODEL 1032S

Applicant Ibt SA

K number K043336

View details →

KXK 2005-01-06

IMPLANT SCIENCES CORP, MODEL HDR-4140

Applicant Implant Sciences Corp.

K number K042864

View details →

KXK 2004-12-09

BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER

Applicant Best Medical International, Inc.

K number K043117

View details →

KXK 2004-11-18

BEST MODEL # 81-01 SERIES IR-192 SOURCES

Applicant Best Medical International, Inc.

K number K042786

View details →

KXK 2004-07-22

OPTISOURCE, MODEL 1032P

Applicant International Brachytherapy S.A.

K number K040766

View details →

KXK 2004-07-16

EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)

Applicant Ibt SA

K number K041702

View details →

KXK 2004-07-02

SOURCELINK

Applicant C.R. Bard, Inc.

K number K041576

View details →

KXK 2004-04-08

BRACHYTHERAPY STRAND DEVICE

Applicant Bebig Isotopen-Und Medizintechnik GmbH

K number K040339

View details →

KXK 2004-04-08

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A

Applicant Isoaid, LLC

K number K033770

View details →

KXK 2004-01-30

CP SLEEVE AND RIVER SLEEVE

Applicant Cp Medical

K number K034062

View details →

KXK 2003-12-30

BEBIG ISOSEED I-125

Applicant Bebig Isotopen-Und Medizintechnik GmbH

K number K033781

View details →

KXK 2003-07-02

READI-STRAND, MODEL PSSTRAND

Applicant Worldwide Medical Technologies, LLC

K number K023179

View details →

KXK 2003-06-10

SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000

Applicant Med-Tec,Inc.

K number K021360

View details →

KXK 2003-06-09

READI-STRAND, MODEL PSSTRAND

Applicant Worldwide Medical Technologies, LLC

K number K022705

View details →

KXK 2003-05-21

VARISEED 7.1

Applicant Varian Medical Systems

K number K030534

View details →

KXK 2003-05-06

READI-LOAD SYSTEM, MODEL PSS 1820RL

Applicant Worldwide Medical Technologies, LLC

K number K022389

View details →

KXK 2003-04-10

I-125 RAPID STRAND, MODEL 7000

Applicant Amersham Health

K number K030594

View details →

KXK 2003-04-07

SEED LINK

Applicant Implant Sciences Corp.

K number K023073

View details →

KXK 2003-03-28

LAWRENCE CSERION, MODEL CS-1

Applicant Isoray, Inc.

K number K030162

View details →

KXK 2003-03-28

SEEDLINKS, MODELS 70301, 70302, 70303

Applicant Sourcetech Medical, LLC

K number K023210

View details →

KXK 2003-03-17

ALTON PT STEPPER

Applicant Alton Design, LLC

K number K024183

View details →

KXK 2003-03-12

GAMMAMED 212 AND 232 SOURCE ASSEMBLY

Applicant Varian Medical Systems

K number K030745

View details →

KXK 2003-03-11

OPTIDOS

Applicant Ptw-New York Corp.

K number K010705

View details →

KXK 2002-12-17

ISOROD PD-103 IMPLANT, MODEL ATI-PD-103

Applicant Ati Medical, Inc.

K number K020683

View details →

KXK 2002-12-04

I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE

Applicant Implant Sciences Corp.

K number K023242

View details →

KXK 2002-07-29

READI-STRAND; MODEL PSSTRAND

Applicant Worldwide Medical Technologies, LLC

K number K020337

View details →

KXK 2002-07-13

SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL

Applicant Cp Medical

K number K021311

View details →

KXK 2002-05-20

ISOSEEDS I-125

Applicant Bebig Isotopen-Und Medizintechnik GmbH

K number K021343

View details →

KXK 2002-02-22

CP-SLEEVE

Applicant Cp Medical

K number K013975

View details →

KXK 2002-01-24

MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS

Applicant Cp Medical

K number K013964

View details →

KXK 2001-12-05

GENETRA

Applicant Radiomed Corporation

K number K013660

View details →

KXK 2001-09-04

ACCU-SPACE ABSORBABLE SEEDING SPACERS

Applicant Cp Medical

K number K010621

View details →

KXK 2001-08-31

MBI PD-103 SL; MBI PD-103 SH

Applicant Mills Biopharmaceuticals, Inc.

K number K011427

View details →

KXK 2001-07-12

INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S

Applicant Ibt, Inc.

K number K011155

View details →

KXK 2001-07-10

ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125

Applicant Isoaid

K number K011205

View details →

KXK 2001-06-25

BRACHYSEED PD-103 MODELS #PD1

Applicant Draximage, Inc.

K number K011119

View details →

KXK 2001-04-26

THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200

Applicant Theragenics Corp.

K number K010283

View details →

KXK 2001-04-25

GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005

Applicant Proxima Therapeutics, Inc.

K number K003206

View details →

KXK 2001-04-11

ECHOSEED/IODINE-125 SEEDS, MODEL 6733

Applicant Medi-Physics Inc. Dba Nycomed Amersham Imaging

K number K010821

View details →

KXK 2001-02-02

SELECT SEED I-125

Applicant Nucletron Corp.

K number K002429

View details →

KXK 2000-10-24

RADIOMED SOURCE

Applicant Radiomed Corp.

K number K001070

View details →

KXK 2000-10-23

RE-ENTRANT CHAMBER, MODEL 1008 OR 44D

Applicant Sun Nuclear Corp.

K number K002446

View details →

KXK 2000-09-19

PROSTEC 125I BRANCHYTHERAPY SNAPSEED

Applicant Prostec, LLC

K number K001366

View details →

KXK 2000-09-07

LOOK COLLAGEN SPACERS, MODEL 1514B

Applicant Surgical Specialties Corp

K number K001765

View details →

KXK 2000-08-22

BRACHYSEED

Applicant Draximage, Inc.

K number K000475

View details →

KXK 2000-07-17

PHARMASEED, MODEL BT-125-3

Applicant Syncor Pharmaceuticals, Inc.

K number K994018

View details →

KXK 2000-07-14

PHARMASEED, MODEL BT-103-3

Applicant Syncor Pharmaceuticals, Inc.

K number K994016

View details →

KXK 2000-06-09

PHARMASEED, MODEL BT-125-2

Applicant Syncor International, Inc.

K number K993701

View details →

KXK 2000-06-02

PHARMASEED, MODEL BT-103-2

Applicant Syncor International, Inc.

K number K993700

View details →

KXK 2000-03-31

ISOSEED PD-103

Applicant Bebig Isotopentechnik GmbH

K number K993552

View details →