KXK · Source, Brachytherapy, Radionuclide
Radiology · 21 CFR 892.5730 · Class 2
Overview
| Product Code | KXK |
|---|---|
| Device Name | Source, Brachytherapy, Radionuclide |
| Regulation | 21 CFR 892.5730 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| Implant | Yes |
Identification
A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.
Classification Rationale
Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 151)
Showing 20 most recent of 151 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252296 | OncoPatch | Oncopatch, Inc. | Dec 5, 2025 | SESE |
| K242818 | IsoSphere | Isoaid, LLC | Jul 15, 2025 | SESE |
| K223465 | RadianceTx Radionuclide Brachytherapy Source | Radiance Therapeutics, Inc. | Jan 11, 2023 | SESE |
| K221539 | GammaTile | Gt Medical Technologies | Nov 9, 2022 | SESE |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles | Isoray Medical, Inc. | Dec 31, 2020 | SESE |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | Lv Liberty Vision Corporation | May 29, 2020 | SESE |
| K190839 | GammaTile | Gt Medical Technologies | Jan 23, 2020 | SESE |
| K191324 | CivaDerm | Civatech Oncology, Inc. | Sep 20, 2019 | SESE |
| K190296 | GammaTile | Gt Medical Technologies | Mar 13, 2019 | SESE |
| K180515 | GammaTile | Isoray Medical, Inc. | Jul 6, 2018 | SESE |
| K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | Aug 25, 2017 | SESE |
| K163572 | LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source | Lv Liberty Vision Corp. | Mar 15, 2017 | SESE |
| K163206 | SMD-Sr90-DA Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | Dec 15, 2016 | SESE |
| K162573 | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source | Source Production and Equipment Co., Inc. | Nov 4, 2016 | SESE |
| K161396 | SPEC Model M23 | Source Production and Equipment Co., Inc. | Aug 17, 2016 | SESE |
| K161395 | SPEC Model M13 | Source Production and Equipment Co., Inc. | Jul 6, 2016 | SESE |
| K150895 | SPEC Model M16 | Source Production and Equipment Co., Inc. | Jun 19, 2015 | SESE |
| K150636 | VariSeed 9.0 | Varian Medical Systems, Inc. | May 8, 2015 | SESE |
| K142701 | SMD Sr90-1 Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | Dec 19, 2014 | SESE |
| K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | Isoaid, LLC | Dec 5, 2014 | SESE |
Top Applicants
- Cp Medical — 6 clearances
- Implant Sciences Corp. — 6 clearances
- Worldwide Medical Technologies, LLC — 6 clearances
- C.R. Bard, Inc. — 5 clearances
- Isoaid, LLC — 5 clearances
