IsoSphere
FDA 510(k) K242818 · Isoaid, LLC
510(k) numberK242818
Submission
- Device name
- IsoSphere
- Applicant
- Isoaid, LLC
Port Richey, FL, US - Received
- September 18, 2024
- Decision date
- July 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KXK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252296 | OncoPatchKXK · Traditional | Oncopatch, Inc. | 12/05/2025SE |
| K223465 | RadianceTx Radionuclide Brachytherapy SourceKXK · Traditional | Radiance Therapeutics, Inc. | 01/11/2023SE |
| K221539 | GammaTileKXK · Traditional | Gt Medical Technologies | 11/09/2022SE |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional | Isoray Medical, Inc. | 12/31/2020SE |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special | Lv Liberty Vision Corporation | 05/29/2020SE |
| K190839 | GammaTileKXK · Traditional | Gt Medical Technologies | 01/23/2020SE |
| K191324 | CivaDermKXK · Traditional | Civatech Oncology, Inc. | 09/20/2019SE |
| K190296 | GammaTileKXK · Special | Gt Medical Technologies | 03/13/2019SE |
| K180515 | GammaTileKXK · Traditional | Isoray Medical, Inc. | 07/06/2018SE |
| K171487 | Sirius MRI Marker NSKXK · Traditional | C4 Imaging, LLC | 08/25/2017SE |
More from C4 Imaging, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K141701 | I-125 RSLN [Radioactive Seed and Localization Needle]KXK · Traditional | 12/05/2014SE |
| K113210 | Advantage-Strand/Advantage-Load Brachytherapy KitKXK · Traditional | 08/10/2012SE |
| K091117 | Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model IaslbkaKXK · Traditional | 09/15/2009SE |
| K033770 | Isoaid Advantage PD-103, Model IAPD-103AKXK · Traditional | 04/08/2004SE |
| K011205 | Isoaid Iodine Brachtherapy Seeds, Model Advantage I-125KXK · Traditional | 07/10/2001SE |
Questions and answers
When was IsoSphere cleared by the FDA?
IsoSphere (K242818) received a 510(k) decision of Substantially Equivalent on July 15, 2025, 300 days after the submission was received.
What is the product code of K242818?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.