Product code KXK
- Device name
- Source, Brachytherapy, Radionuclide
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5730
- Review panel
- RA
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252296 | OncoPatch | Oncopatch, Inc. | 2025-12-05 |
| K242818 | IsoSphere | Isoaid, LLC | 2025-07-15 |
| K223465 | RadianceTx Radionuclide Brachytherapy Source | Radiance Therapeutics, Inc. | 2023-01-11 |
| K221539 | GammaTile | Gt Medical Technologies | 2022-11-09 |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles | Isoray Medical, Inc. | 2020-12-31 |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | Lv Liberty Vision Corporation | 2020-05-29 |
| K190839 | GammaTile | Gt Medical Technologies | 2020-01-23 |
| K191324 | CivaDerm | Civatech Oncology, Inc. | 2019-09-20 |
| K190296 | GammaTile | Gt Medical Technologies | 2019-03-13 |
| K180515 | GammaTile | Isoray Medical, Inc. | 2018-07-06 |
| K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017-08-25 |
| K163572 | LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source | Lv Liberty Vision Corp. | 2017-03-15 |
| K163206 | SMD-Sr90-DA Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | 2016-12-15 |
| K162573 | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source | Source Production and Equipment Co., Inc. | 2016-11-04 |
| K161396 | SPEC Model M23 | Source Production and Equipment Co., Inc. | 2016-08-17 |
| K161395 | SPEC Model M13 | Source Production and Equipment Co., Inc. | 2016-07-06 |
| K150895 | SPEC Model M16 | Source Production and Equipment Co., Inc. | 2015-06-19 |
| K150636 | VariSeed 9.0 | Varian Medical Systems, Inc. | 2015-05-08 |
| K142701 | SMD Sr90-1 Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | 2014-12-19 |
| K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | Isoaid, LLC | 2014-12-05 |
| K142668 | Lesion-Loc Iodine I-125 Seed/Needle | Intramedical Imaging, LLC | 2014-11-21 |
| K141038 | ANT MODEL 1 | Advanced Nuclide Technologies, LLC | 2014-11-12 |
| K140490 | CIVA SHEET PD-103 | Civatech Oncology, Inc. | 2014-08-29 |
| K140849 | ISOSEED | Eckert & Ziegler Bebig GmbH | 2014-07-02 |
| K140856 | BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS | C.R. Bard, Inc. | 2014-05-02 |
| K132969 | SPEC MODEL M15 | Source Production & Equipment Co., Inc. | 2014-01-02 |
| K132996 | CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS | Isoray, Inc. | 2013-12-17 |
| K131689 | MRI MARKER | C4 Imaging, LLC | 2013-11-20 |
| K122704 | BEST LOCALIZATION NEEDLE WITH I-125 SEED | Best Medical Intl. | 2013-01-09 |
| K122764 | RAPID STRAND RX | Medi-Physics, Inc. | 2012-12-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M936IIS4721 | IsoSphere | ISOAID, L.L.C. | 2026-05-12 |
| 10801741184120 | SourceLink™ | Bard Brachytherapy, Inc. | 2020-08-06 |
| 10801741184137 | SourceLink™ | Bard Brachytherapy, Inc. | 2020-08-06 |
| 10790986007038 | FN NEEDLES | C.P. MEDICAL CORPORATION | 2017-11-06 |
| 10790986006307 | FN NEEDLES | C.P. MEDICAL CORPORATION | 2016-02-19 |
| 10790986006314 | FN NEEDLES | C.P. MEDICAL CORPORATION | 2016-02-19 |
| 10790986006321 | FN NEEDLES | C.P. MEDICAL CORPORATION | 2016-02-19 |
| 10790986006338 | FN NEEDLES | C.P. MEDICAL CORPORATION | 2016-02-19 |
| 10790986006345 | FN NEEDLES | C.P. MEDICAL CORPORATION | 2016-02-19 |
| 10790986006291 | FN NEEDLES | C.P. MEDICAL CORPORATION | 2016-02-19 |
| M936IRLS05SSS9 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-11 |
| M936IRLS05S9 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-11 |
| M936IRLS05SS9 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-11 |
| M936IRLS05SS0 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M936IRLS05SSS0 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M936IRLS05S0 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M936IRLS07S0 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M936IMLS9 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M936IMLN9 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M936ILVS9 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M936ILVS0 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M936ILVN9 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M936ILVN0 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M936IEPS9 | Advantage I-125® | ISOAID, L.L.C. | 2016-02-04 |
| M74890050 | GliaSite® Access Tray | ISORAY MEDICAL, INC. | 2015-10-28 |
| M74881600 | Cesitrex™ | ISORAY MEDICAL, INC. | 2015-10-28 |
| M74881500 | Iotrex® | ISORAY MEDICAL, INC. | 2015-10-28 |
| M74810400 | GliaSite® Catheter Tray | ISORAY MEDICAL, INC. | 2015-10-28 |
| M74810300 | GliaSite® Catheter Tray | ISORAY MEDICAL, INC. | 2015-10-28 |
| M74810200 | GliaSite® Catheter Tray | ISORAY MEDICAL, INC. | 2015-10-28 |