# K130678: Biomarc Gold Fiducial Marker

- Pathway: 510(k) (Special)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Apr 12, 2013 after 30 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K001807 (2001). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110772: Biomarc Fiducial Marker, Carbon Medical Technologies, Inc. (2011)
- K071614: Fiducial Markers, Civco (2007) Summary page 1.
- K070436: Biomarc Gold Tissue Marker, Carbon Medical Technologies, Inc. (2007) Summary page 1.

## Most influential descendants
- K132064: Biomarc Fiducial Marker (2014), 1 descendant of its own
- K191797: BiomarC Fiducial Marker (2019), 0 descendants of its own

## Indications for use
The BiomarC Gold Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

Source page: https://510kreport.com/device/K130678
Methodology: https://510kreport.com/methodology