510(k) Report

FDA applicant

C4 Imaging, LLC

Doylestown, PA4 decisions2013–20200 recalls

FDA records 4 decisions for C4 Imaging, LLC (Doylestown, PA) from 2013 to 2020: 4 510(k) clearances. Most are in product codes KXK (Source, Brachytherapy, Radionuclide) and NEU (Marker, Radiographic, Implantable). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided C4 Imaging, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2013: 12017: 12018: 12020: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — C4 Imaging, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KXKSource, Brachytherapy, Radionuclide2decisions
  • NEUMarker, Radiographic, Implantable1decision
  • JAQSystem, Applicator, Radionuclide, Remote-Controlled1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K131689Mri MarkerC4 Imaging, LLC · 20131cites it

What has FDA decided for it lately?

  • K192771C4 Fiducial MarkerC4 Imaging, LLC · 2020
  • K180069HDR MRI Lumen MarkerC4 Imaging, LLC · 2018
  • K171487Sirius MRI Marker NSC4 Imaging, LLC · 2017
  • K131689Mri MarkerC4 Imaging, LLC · 2013

All 4 as C4 Imaging, LLC →