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 | Dec 5, 2025 |
| K242818 | Isoaid | IsoSphere | Jul 15, 2025 |
| K223465 | Radiance Therapeutics | RadianceTx Radionuclide Brachytherapy Source | Jan 11, 2023 |
| K221539 | Gt Medical Technologies | GammaTile | Nov 9, 2022 |
| K202267 | Isoray Medical | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge | Dec 31, 2020 |
| K193602 | Lv Liberty Vision Corporation | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | May 29, 2020 |
| K190839 | Gt Medical Technologies | GammaTile | Jan 23, 2020 |
| K191324 | Civatech Oncology | CivaDerm | Sep 20, 2019 |
| K190296 | Gt Medical Technologies | GammaTile | Mar 13, 2019 |
| K180515 | Isoray Medical | GammaTile | Jul 6, 2018 |
| K171487 | C4 Imaging | Sirius MRI Marker NS | Aug 25, 2017 |
| K163572 | Lv Liberty Vision | LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source | Mar 15, 2017 |
| K163206 | Salutaris Medical Devices | SMD-Sr90-DA Radionuclide Brachytherapy Source | Dec 15, 2016 |
| K162573 | Source Production And Equipment Co | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Sourc | Nov 4, 2016 |
| K161396 | Source Production And Equipment Co | SPEC Model M23 | Aug 17, 2016 |
| K161395 | Source Production And Equipment Co | SPEC Model M13 | Jul 6, 2016 |
| K150895 | Source Production And Equipment Co | SPEC Model M16 | Jun 19, 2015 |
| K150636 | Varian Medical Systems | VariSeed 9.0 | May 8, 2015 |
| K142701 | Salutaris Medical Devices | SMD Sr90-1 Radionuclide Brachytherapy Source | Dec 19, 2014 |
| K141701 | Isoaid | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | Dec 5, 2014 |