KXK — Source, Brachytherapy, Radionuclide Class II
FDA product code KXK covers "Source, Brachytherapy, Radionuclide", a Class II medical device regulated under 21 CFR 892.5730. Submissions are reviewed by the Radiology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252296 | oncopatch | OncoPatch | December 5, 2025 |
| K242818 | isoaid | IsoSphere | July 15, 2025 |
| K223465 | radiance therapeutics | RadianceTx Radionuclide Brachytherapy Source | January 11, 2023 |
| K221539 | gt medical technologies | GammaTile | November 9, 2022 |
| K202267 | isoray medical | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge | December 31, 2020 |
| K193602 | lv liberty vision corporation | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | May 29, 2020 |
| K190839 | gt medical technologies | GammaTile | January 23, 2020 |
| K191324 | civatech oncology | CivaDerm | September 20, 2019 |
| K190296 | gt medical technologies | GammaTile | March 13, 2019 |
| K180515 | isoray medical | GammaTile | July 6, 2018 |
| K171487 | c4 imaging | Sirius MRI Marker NS | August 25, 2017 |
| K163572 | lv liberty vision | LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source | March 15, 2017 |
| K163206 | salutaris medical devices | SMD-Sr90-DA Radionuclide Brachytherapy Source | December 15, 2016 |
| K162573 | source production and equipment co | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Sourc | November 4, 2016 |
| K161396 | source production and equipment co | SPEC Model M23 | August 17, 2016 |
| K161395 | source production and equipment co | SPEC Model M13 | July 6, 2016 |
| K150895 | source production and equipment co | SPEC Model M16 | June 19, 2015 |
| K150636 | varian medical systems | VariSeed 9.0 | May 8, 2015 |
| K142701 | salutaris medical devices | SMD Sr90-1 Radionuclide Brachytherapy Source | December 19, 2014 |
| K141701 | isoaid | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | December 5, 2014 |