# K131689: Mri Marker

- Pathway: 510(k) (Traditional)
- Applicant: C4 Imaging, LLC
- Decided: Nov 20, 2013 after 163 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010621 (2001). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103449: Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers, Riverpoint Medical (2011) Summary page 2.
- K083274: Worldwide Medical Technologies Anchor Marker, Marker Strand and Marker, Biocompatibles, Inc. (2009) Summary page 2.
- K010621: Accu-Space Absorbable Seeding Spacers, Cp Medical (2001) Summary page 2.
- K040766: Optisource, Model 1032P, International Brachytherapy S.A. (2004) Summary page 2.

## Most influential descendants
- K171487: Sirius MRI Marker NS (2017), 0 descendants of its own

## Indications for use
The MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.

Source page: https://510kreport.com/device/K131689
Methodology: https://510kreport.com/methodology