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KXK — Source, Brachytherapy, Radionuclide Class II

FDA Device Classification

Classification Details

Product Code
KXK
Device Class
Class II
Regulation Number
892.5730
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252296oncopatchOncoPatchDecember 5, 2025
K242818isoaidIsoSphereJuly 15, 2025
K223465radiance therapeuticsRadianceTx Radionuclide Brachytherapy SourceJanuary 11, 2023
K221539gt medical technologiesGammaTileNovember 9, 2022
K202267isoray medicalSirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 GaugeDecember 31, 2020
K193602lv liberty vision corporationLV Liberty Vision Model 1 90Yttrium Brachytherapy SourceMay 29, 2020
K190839gt medical technologiesGammaTileJanuary 23, 2020
K191324civatech oncologyCivaDermSeptember 20, 2019
K190296gt medical technologiesGammaTileMarch 13, 2019
K180515isoray medicalGammaTileJuly 6, 2018
K171487c4 imagingSirius MRI Marker NSAugust 25, 2017
K163572lv liberty visionLV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceMarch 15, 2017
K163206salutaris medical devicesSMD-Sr90-DA Radionuclide Brachytherapy SourceDecember 15, 2016
K162573source production and equipment coSource Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy SourcNovember 4, 2016
K161396source production and equipment coSPEC Model M23August 17, 2016
K161395source production and equipment coSPEC Model M13July 6, 2016
K150895source production and equipment coSPEC Model M16June 19, 2015
K150636varian medical systemsVariSeed 9.0May 8, 2015
K142701salutaris medical devicesSMD Sr90-1 Radionuclide Brachytherapy SourceDecember 19, 2014
K141701isoaidI-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]December 5, 2014