Atlas FDA

KXK

151 FDA 510(k) clearances · Product code

90 daysmedian time to decision
284 days90th percentile
151clearances measured

FDA profile

Official device name
Source, Brachytherapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Medical specialty
Radiology
Flags
Implant
Adverse events (MAUDE)
2016: 40 · 2017: 41 · 2018: 28 · 2020: 15 · 2021: 62 · 2022: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OncoPatch (K252296)Oncopatch, Inc.2025-12-05
IsoSphere (K242818)Isoaid, LLC2025-07-15
RadianceTx Radionuclide Brachytherapy Source (K223465)Radiance Therapeutics, Inc.2023-01-11
GammaTile (K221539)Gt Medical Technologies2022-11-09
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles (K202267)Isoray Medical, Inc.2020-12-31
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (K193602)Lv Liberty Vision Corporation2020-05-29
GammaTile (K190839)Gt Medical Technologies2020-01-23
CivaDerm (K191324)Civatech Oncology, Inc.2019-09-20
GammaTile (K190296)Gt Medical Technologies2019-03-13
GammaTile (K180515)Isoray Medical, Inc.2018-07-06
Sirius MRI Marker NS (K171487)C4 Imaging, LLC2017-08-25
LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source (K163572)Lv Liberty Vision Corp.2017-03-15
SMD-Sr90-DA Radionuclide Brachytherapy Source (K163206)Salutaris Medical Devices, Inc.2016-12-15
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source (K162573)Source Production and Equipment Co., Inc.2016-11-04
SPEC Model M23 (K161396)Source Production and Equipment Co., Inc.2016-08-17
SPEC Model M13 (K161395)Source Production and Equipment Co., Inc.2016-07-06
SPEC Model M16 (K150895)Source Production and Equipment Co., Inc.2015-06-19
VariSeed 9.0 (K150636)Varian Medical Systems, Inc.2015-05-08
SMD Sr90-1 Radionuclide Brachytherapy Source (K142701)Salutaris Medical Devices, Inc.2014-12-19
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] (K141701)Isoaid, LLC2014-12-05
Lesion-Loc Iodine I-125 Seed/Needle (K142668)Intramedical Imaging, LLC2014-11-21
ANT MODEL 1 (K141038)Advanced Nuclide Technologies, LLC2014-11-12
CIVA SHEET PD-103 (K140490)Civatech Oncology, Inc.2014-08-29
ISOSEED (K140849)Eckert & Ziegler Bebig GmbH2014-07-02
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS (K140856)C.R. Bard, Inc.2014-05-02
SPEC MODEL M15 (K132969)Source Production & Equipment Co., Inc.2014-01-02
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS (K132996)Isoray, Inc.2013-12-17
MRI MARKER (K131689)C4 Imaging, LLC2013-11-20
BEST LOCALIZATION NEEDLE WITH I-125 SEED (K122704)Best Medical Intl.2013-01-09
RAPID STRAND RX (K122764)Medi-Physics, Inc.2012-12-28
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT (K113210)Isoaid, LLC2012-08-10
PRE-LOADED GOLD VISICOIL CK MARKER (K120859)Radiomed Corporation2012-04-19
RADIOACTIVE SEED LOCALIZATION NEEDLE (K111979)Biocompatibles, Inc.2011-10-18
GLIASITE RTS (K111931)Isoray Medical, Inc.2011-08-05
AOS ORION IR-192 SOURCE CABLE (K102811)Alpha-Omega Services, Inc.2011-06-02
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS (K103449)Riverpoint Medical2011-02-25
I-SEED (K103319)Theragenics Corp.2011-01-03
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 (K100847)Biocompatibles, Inc.2010-05-21
RADIONUCLIDE BRACHYTHERAPY SOURCE (K093663)C.R. Bard, Inc.2009-12-23
ACU007S (K092522)Oncology Systems, Inc.2009-11-20
ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA (K091117)Isoaid, LLC2009-09-15
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 (K092458)Isoray Medical, Inc.2009-08-28
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 (K092136)Isoray Medical, Inc.2009-08-07
SPEC MODEL M-31 (K090366)Source Production & Equipment Co., Inc.2009-04-22
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER (K083274)Biocompatibles, Inc.2009-01-08
CIVASTRING PD-103 (K082159)Civatech Oncology, Inc.2008-09-30
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 (K072296)Theragenics Corp.2007-09-26
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS (K071550)Cp Medical2007-07-18
AOS MARKER SEEDS (K062825)Alpha-Omega Services, Inc.2007-05-22
IMPLANT SCIENCES CORP. MODEL HDR 4454 (K070468)Implant Sciences Corp.2007-03-23
BRACHYSCIENCES STRANDPORT (K062214)Worldwide Medical Technologies, LLC2007-03-01
RAPID STRAND RX (K063177)Oncura, Inc.2006-11-30
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE (K062384)Isoray, Inc.2006-11-09
BEST STRAND AND BEST SPACER (K061638)Best Medical International, Inc.2006-08-04
SURTRAK IMPLANTATION KIT (K060679)North American Scientific, Inc.2006-04-21
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE (K060636)C.R. Bard, Inc.2006-04-19
CURAY CUSTOM SEED ARRAY (K053595)Biolucent, Inc.2006-02-28
NSTRAND IMPLANTATION KIT (K052024)North American Scientific, Inc.2005-09-07
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS (K043246)C.R. Bard, Inc.2005-02-02
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 (K043596)Theragenics Corp.2005-01-26
OPTISTRAND, MODEL 1032S (K043336)Ibt SA2005-01-21
IMPLANT SCIENCES CORP, MODEL HDR-4140 (K042864)Implant Sciences Corp.2005-01-06
BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER (K043117)Best Medical International, Inc.2004-12-09
BEST MODEL # 81-01 SERIES IR-192 SOURCES (K042786)Best Medical International, Inc.2004-11-18
OPTISOURCE, MODEL 1032P (K040766)International Brachytherapy S.A.2004-07-22
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) (K041702)Ibt SA2004-07-16
SOURCELINK (K041576)C.R. Bard, Inc.2004-07-02
BRACHYTHERAPY STRAND DEVICE (K040339)Bebig Isotopen-Und Medizintechnik GmbH2004-04-08
ISOAID ADVANTAGE PD-103, MODEL IAPD-103A (K033770)Isoaid, LLC2004-04-08
CP SLEEVE AND RIVER SLEEVE (K034062)Cp Medical2004-01-30
BEBIG ISOSEED I-125 (K033781)Bebig Isotopen-Und Medizintechnik GmbH2003-12-30
READI-STRAND, MODEL PSSTRAND (K023179)Worldwide Medical Technologies, LLC2003-07-02
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 (K021360)Med-Tec,Inc.2003-06-10
READI-STRAND, MODEL PSSTRAND (K022705)Worldwide Medical Technologies, LLC2003-06-09
VARISEED 7.1 (K030534)Varian Medical Systems2003-05-21
READI-LOAD SYSTEM, MODEL PSS 1820RL (K022389)Worldwide Medical Technologies, LLC2003-05-06
I-125 RAPID STRAND, MODEL 7000 (K030594)Amersham Health2003-04-10
SEED LINK (K023073)Implant Sciences Corp.2003-04-07
SEEDLINKS, MODELS 70301, 70302, 70303 (K023210)Sourcetech Medical, LLC2003-03-28
LAWRENCE CSERION, MODEL CS-1 (K030162)Isoray, Inc.2003-03-28
ALTON PT STEPPER (K024183)Alton Design, LLC2003-03-17
GAMMAMED 212 AND 232 SOURCE ASSEMBLY (K030745)Varian Medical Systems2003-03-12
OPTIDOS (K010705)Ptw-New York Corp.2003-03-11
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 (K020683)Ati Medical, Inc.2002-12-17
I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE (K023242)Implant Sciences Corp.2002-12-04
READI-STRAND; MODEL PSSTRAND (K020337)Worldwide Medical Technologies, LLC2002-07-29
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL (K021311)Cp Medical2002-07-13
ISOSEEDS I-125 (K021343)Bebig Isotopen-Und Medizintechnik GmbH2002-05-20
CP-SLEEVE (K013975)Cp Medical2002-02-22
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS (K013964)Cp Medical2002-01-24
GENETRA (K013660)Radiomed Corporation2001-12-05
ACCU-SPACE ABSORBABLE SEEDING SPACERS (K010621)Cp Medical2001-09-04
MBI PD-103 SL; MBI PD-103 SH (K011427)Mills Biopharmaceuticals, Inc.2001-08-31
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S (K011155)Ibt, Inc.2001-07-12
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 (K011205)Isoaid2001-07-10
BRACHYSEED PD-103 MODELS #PD1 (K011119)Draximage, Inc.2001-06-25
THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 (K010283)Theragenics Corp.2001-04-26
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 (K003206)Proxima Therapeutics, Inc.2001-04-25
ECHOSEED/IODINE-125 SEEDS, MODEL 6733 (K010821)Medi-Physics Inc. Dba Nycomed Amersham Imaging2001-04-11
SELECT SEED I-125 (K002429)Nucletron Corp.2001-02-02
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