Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5730](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5730) → KXK — Source, Brachytherapy, Radionuclide # KXK · Source, Brachytherapy, Radionuclide _Radiology · 21 CFR 892.5730 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK ## Overview - **Product Code:** KXK - **Device Name:** Source, Brachytherapy, Radionuclide - **Regulation:** [21 CFR 892.5730](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5730) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **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](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K252296.md) | OncoPatch | Oncopatch, Inc. | Dec 5, 2025 | SESE | | [K242818](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K242818.md) | IsoSphere | Isoaid, LLC | Jul 15, 2025 | SESE | | [K223465](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K223465.md) | RadianceTx Radionuclide Brachytherapy Source | Radiance Therapeutics, Inc. | Jan 11, 2023 | SESE | | [K221539](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K221539.md) | GammaTile | Gt Medical Technologies | Nov 9, 2022 | SESE | | [K202267](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K202267.md) | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles | Isoray Medical, Inc. | Dec 31, 2020 | SESE | | [K193602](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K193602.md) | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | Lv Liberty Vision Corporation | May 29, 2020 | SESE | | [K190839](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K190839.md) | GammaTile | Gt Medical Technologies | Jan 23, 2020 | SESE | | [K191324](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K191324.md) | CivaDerm | Civatech Oncology, Inc. | Sep 20, 2019 | SESE | | [K190296](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K190296.md) | GammaTile | Gt Medical Technologies | Mar 13, 2019 | SESE | | [K180515](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K180515.md) | GammaTile | Isoray Medical, Inc. | Jul 6, 2018 | SESE | | [K171487](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K171487.md) | Sirius MRI Marker NS | C4 Imaging, LLC | Aug 25, 2017 | SESE | | [K163572](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K163572.md) | LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source | Lv Liberty Vision Corp. | Mar 15, 2017 | SESE | | [K163206](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K163206.md) | SMD-Sr90-DA Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | Dec 15, 2016 | SESE | | [K162573](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K162573.md) | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source | Source Production and Equipment Co., Inc. | Nov 4, 2016 | SESE | | [K161396](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K161396.md) | SPEC Model M23 | Source Production and Equipment Co., Inc. | Aug 17, 2016 | SESE | | [K161395](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K161395.md) | SPEC Model M13 | Source Production and Equipment Co., Inc. | Jul 6, 2016 | SESE | | [K150895](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K150895.md) | SPEC Model M16 | Source Production and Equipment Co., Inc. | Jun 19, 2015 | SESE | | [K150636](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K150636.md) | VariSeed 9.0 | Varian Medical Systems, Inc. | May 8, 2015 | SESE | | [K142701](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K142701.md) | SMD Sr90-1 Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | Dec 19, 2014 | SESE | | [K141701](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K141701.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com