# K192771: C4 Fiducial Marker

- Pathway: 510(k) (Traditional)
- Applicant: C4 Imaging, LLC
- Decided: Oct 21, 2020 after 387 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- 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 K001807 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102506: Mixed Media Marker, Cortex Manufacturing, Inc. (2011) Summary page 5.
- K063193: Modification to Biomarc Tissue Marker, Carbon Medical Technologies, Inc. (2006) Summary page 5.

## Indications for use
The C4 Fiducial Marker is indicated to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The device can be visualized using MRI, CT or x-ray, and provides a reference from which other procedures can be guided.

Source page: https://510kreport.com/device/K192771
Methodology: https://510kreport.com/methodology