Source, Brachytherapy, Radionuclide

Product Code: KXK

Radiology Radioisotope Therapy Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.5730


Radiation TypeIonizing
Radition SafetyNone
Annual ReportsNo

Products Classified as KXK

5379Source, Brachytherapy, RadionuclideRadionuclide Brachytherapy Source.

Total Product Life Cycle (TPLC) Devices

5379Source, Brachytherapy, RadionuclideRadionuclide Brachytherapy Source.

Pre-market Notifications for KXK

K221539GammaTileGT Medical Technologies
K202267Sirius MRI Markers, Cs-131 Preloaded Strands With Sirius MRI Markers In 18 Gauge NeedlesIsoray Medical, Inc.
K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLV Liberty Vision Corporation
K191324CivaDermCivaTech Oncology Inc.
K190839GammaTileGT Medical Technologies
K190296GammaTileGT Medical Technologies
K180515GammaTileIsoray Medical Inc.
K171487Sirius MRI Marker NSC4 Imaging, LLC
K163572LV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceLV Liberty Vision Corp.
K163206SMD-Sr90-DA Radionuclide Brachytherapy SourceSalutaris Medical Devices, Inc.
K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy SourceSOURCE PRODUCTION AND EQUIPMENT CO., INC.
K161396SPEC Model M23Source Production And Equipment Co.,Inc.
K161395SPEC Model M13Source Production And Equipment Co.,Inc.
K150895SPEC Model M16Source Production And Equipment Co.,Inc.
K150636VariSeed 9.0VARIAN MEDICAL SYSTEMS, INC.

Global Unique Device Identification Database

00801741098703Source, brachytherapy, radionuclide
00801741098697Source, brachytherapy, radionuclide
00801741098666Source, brachytherapy, radionuclide
00801741098659Source, brachytherapy, radionuclide
00801741098642Source, brachytherapy, radionuclide
00801741098635Source, brachytherapy, radionuclide
00801741098628Source, brachytherapy, radionuclide
00801741098611Source, brachytherapy, radionuclide
00801741098604Source, brachytherapy, radionuclide
00801741098598Source, brachytherapy, radionuclide
00801741098581Source, brachytherapy, radionuclide
00801741098376Source, brachytherapy, radionuclide
00801741091353Source, brachytherapy, radionuclide
00801741086786Source, brachytherapy, radionuclide
00801741086779Source, brachytherapy, radionuclide

Maude Adverse Events

BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSC.R. BARD, INC. (COVINGTON) -10182332020-02-21
BARD? QUICKLINK? CARTRIDGESC.R. BARD, INC. (COVINGTON) -10182332020-02-14
I-125 QUICKLINK CARTRIDGE (IN PEWTER TRAY), STERILEC.R. BARD, INC. (COVINGTON) -10182332020-02-13
BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSC.R. BARD, INC. (COVINGTON) -10182332020-02-07
PROXCELAN MODEL CS-1ISORAY MEDICAL, INC. / SHANNON GOLDENSTEIN2019-11-06
BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSC.R. BARD, INC. (COVINGTON) -10182332019-10-10
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESC.R. BARD, INC. (COVINGTON) -10182332019-07-26
SOURCE, BRACHYTHERAPY, RADIONUCLIDEUNK2019-05-15
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESBARD BRACHYTHERAPY, INC. -14245262019-03-15
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESBARD BRACHYTHERAPY, INC. -14245262019-03-15
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN READYLINK?BARD BRACHYTHERAPY, INC. -14245262019-01-10
BRACHYSOURCE? MODEL STM1251 I-125 BRACHYTHERAPY SEEDBARD BRACHYTHERAPY, INC. -14245262018-11-26
QUICKLINK? CARTRIDGE 5.0MM EXTENSION SOURCELINK?BARD BRACHYTHERAPY, INC. -14245262018-11-21
QUICKLINK? CARTRIDGE 5.0MM EXTENSION SOURCELINK?BARD BRACHYTHERAPY, INC. -14245262018-11-16
BRACHY SOURCEBARD BRACHYTHERAPY, INC. -14245262018-08-17
HDR BRACHTHERAPY SYSTEMELEKTA, INC.2018-06-13
MODEL 200 THERASEED? PALLADIUM-103 IN CARTRIDGESBARD BRACHYTHERAPY, INC. -14245262018-05-17
MODEL 200 THERASEED? PALLADIUM-103 IN READYLINK?BARD BRACHYTHERAPY, INC. -14245262018-05-17
BRACHYTHERAPYUNK2018-05-11
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDBARD BRACHYTHERAPY, INC. -14245262018-05-04
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESBARD BRACHYTHERAPY, INC. -14245262018-05-03
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESBARD BRACHYTHERAPY, INC. -14245262018-05-03
BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSBARD BRACHYTHERAPY, INC. -14245262018-03-29
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDBARD BRACHYTHERAPY, INC. -14245262018-03-27
CESIUM RADIOACTIVE SEEDS2018-03-26
QUICKLINK? CARTRIDGE 5.0MM EXTENSION SOURCELINK?BARD BRACHYTHERAPY, INC. -14245262018-03-21
BARD? BRACHYSOURCE? I-125 IMPLANT SEED PRELOADED IN NEEDLESBARD BRACHYTHERAPY, INC. -14245262018-03-20
BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSBARD BRACHYTHERAPY, INC. -14245262018-02-26
QUICKLINK? CARTRIDGE 0.5MM SEED-TO-SEED SOURCELINKBARD BRACHYTHERAPY, INC. -14245262018-02-05
QUICKLINK? CARTRIDGE 5.0MM EXTENSION SOURCELINK?BARD BRACHYTHERAPY, INC. -14245262018-02-05
QUICKLINK? CARTRIDGE 5.5MM STANDARD SOURCELINK?BARD BRACHYTHERAPY, INC. -14245262018-02-05
QUICKLINKBARD BRACHYTHERAPY, INC. -14245262018-02-03
BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSBARD BRACHYTHERAPY, INC. -14245262018-02-02
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESBARD BRACHYTHERAPY, INC. -14245262018-02-01
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESBARD BRACHYTHERAPY, INC. -14245262018-02-01
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESBARD BRACHYTHERAPY, INC. -14245262018-02-01
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESBARD BRACHYTHERAPY, INC. -14245262018-01-30
BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSBARD BRACHYTHERAPY, INC. -14245262018-01-12
BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSBARD BRACHYTHERAPY, INC. -14245262018-01-02
BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSBARD BRACHYTHERAPY, INC. -14245262017-12-29
BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSBARD BRACHYTHERAPY, INC. -14245262017-12-29
SEEDS MARKERSBEST MEDICAL INTERNATIONAL INC.2017-12-14
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDBARD BRACHYTHERAPY, INC. -14245262017-11-21
I-125 QUICKLINK CARTRIDGE (IN PEWTER TRAY), STERILEBARD BRACHYTHERAPY, INC. -14245262017-11-17
BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDSBARD BRACHYTHERAPY, INC. -14245262017-11-17
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDBARD BRACHYTHERAPY, INC. -14245262017-11-09
BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESBARD BRACHYTHERAPY, INC. -14245262017-10-18
QUICKLINK? CARTRIDGE 0.5MM SEED-TO-SEED SOURCELINK?BARD BRACHYTHERAPY, INC. -14245262017-10-17
BARD? BRACHYSOURCE? I-125 IMPLANT SEED PRELOADED IN NEEDLESBARD BRACHYTHERAPY, INC. -14245262017-10-12
BARD? BRACHYSOURCE? I-125 IMPLANT SEED PRELOADED IN NEEDLESBARD BRACHYTHERAPY, INC. -14245262017-10-12

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