MRI Marker
510(k) K131689
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131689 | Date20 Nov 2013 | StatusActive |
Official records
- FDA 510(k) database K131689
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KXK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5730
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
An MRI Marker is a device used as a source in brachytherapy radionuclide applications. It is designed to be visible under MRI imaging to assist in localization and treatment planning.
The device is supplied non-sterile and is intended for reusable use. It is manufactured by C4 Imaging, LLC and has received FDA 510(k) clearance under K131689, with product code KXK and classification as a Class II device in the Radiology specialty.
Devices cleared under K131689
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Sirius MRI Marker C-01-99-0014 | F-01-01-0001 / C-01-99-0014 | 00863593000204 | — | No longer on the market |
| Sirius MRI Marker F-01-01-0001 | F-01-01-0001 / F-01-01-0001 | 00863593000211 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code KXK (Source, Brachytherapy, Radionuclide).
- RadianceTx Radionuclide Brachytherapy Source by Radiance Therapeutics, Inc.
- TheraSeed XX50x by THERAGENICS CORP.
- I-PLANT, MODEL 3500 by Implant Sciences Corp.
- ALTON PT STEPPER by Alton Design, LLC
- NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE by North American Scientific, Inc.
- CIVASTRING PD-103 by CivaTech Oncology Inc.
- SPEC MODEL M15 by Source Production & Equipment Co., Inc.
- THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 by THERAGENICS CORP.
- I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE by Implant Sciences Corp.
- RE-ENTRANT CHAMBER, MODEL 1008 OR 44D by Sun Nuclear Corporation