510(k) · Cleared
ClearedHDR MRI Lumen Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C4 Imaging, LLC · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Apr 27, 2018 as substantially equivalent to K091154 (Nucletron Corporation, 2009) after a 108-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Apr 27, 2018
- Review
- 108 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K864210 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 3 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 2 generations backK983341 Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal…Nucletron Corp. · 1999
- 1 generation backK091154 Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270…Nucletron Corporation · 2009
- This deviceK180069 HDR MRI Lumen MarkerC4 Imaging, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −3 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −2 | K983341 | Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR… | Nucletron Corp. | 1999 | — |
| −1 | K091154 | Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270… | Nucletron Corporation | 2009 | — |
| 0 (this device) | K180069 | HDR MRI Lumen Marker | C4 Imaging, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAQ device
- #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091154 | Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270, Interstitial Ring…Summary page 5…radionuclide applicator system accessory Predicate Device Interstitial Ring CT/MR Applicator Set K091154 Nucletron Device Description The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube co… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K091154.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 2025
MAUDE reports naming product code JAQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 48 | 0 | 13 |
| 2008 | 10 | 34 | 5 | 32 |
| 2009 | 10 | 27 | 1 | 35 |
| 2010 | 2 | — | 2 | 36 |
| 2011 | 2 | — | 13 | 42 |
| 2012 | 7 | 89 | 5 | 34 |
| 2013 | 6 | 100 | 1 | 43 |
| 2014 | 7 | 116 | 0 | 18 |
| 2015 | 11 | 183 | 0 | 7 |
| 2016 | 6 | 154 | 0 | 3 |
| 2017 | 7 | 229 | 0 | 5 |
| 2018 | 7 | 252 | 0 | 2 |
| 2019 | 2 | — | 1 | 8 |
| 2020 | 4 | 62 | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 10 | 126 | 0 | 1 |
| 2025 | 6 | 91 | 0 | 3 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
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…
Read the full statement (160 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180069: HDR MRI Lumen Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180069
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026