MRI Marker
FDA 510(k) K131689 · C4 Imaging, LLC
510(k) numberK131689
Submission
- Device name
- MRI Marker
- Applicant
- C4 Imaging, LLC
Bloomfield Hills, MI, US - Received
- June 10, 2013
- Decision date
- November 20, 2013
- 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 |
| K242818 | IsoSphereKXK · Traditional | Isoaid, LLC | 07/15/2025SE |
| 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 |
More from Isoray Medical, Inc.
Questions and answers
When was MRI Marker cleared by the FDA?
MRI Marker (K131689) received a 510(k) decision of Substantially Equivalent on November 20, 2013, 163 days after the submission was received.
What is the product code of K131689?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.