# K180069: HDR MRI Lumen Marker

- Pathway: 510(k) (Traditional)
- Applicant: C4 Imaging, LLC
- Decided: Apr 27, 2018 after 108 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864210 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091154: Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270, Interstitial Ring CT/MR Applicator Set,Model 110.330,, Nucletron Corporation (2009) Summary page 5.

## Indications for use
The HDR MRI Lumen Marker is indicated as an accessory for use with FDA Market Cleared remote controlled radionuclide applicator systems that are used to treat tumors that are indicated for treatment with high dose rate (HDR) brachytherapy. The HDR MRI Lumen Marker is indicated for temporary placement in HDR applicator lumens. The HDR MRI Lumen Marker is intended to facilitate the identification of HDR applicator treatment lumens. It is intended to be non-patient contacting and only placed in applicators that are designed to prevent patient tissue or bodily fluids accessing the inner lumen. Once placed in an HDR applicator lumen the HDR MRI Lumen Marker is intended to be imaged with MRI. It is removed after MR imaging and prior to the placement of a radioactive source. The HDR MRI Lumen Marker is intended for use in a single patient and can be used more than once if required for a single course of treatment in a single patient.

Source page: https://510kreport.com/device/K180069
Methodology: https://510kreport.com/methodology