# K191797: BiomarC Fiducial Marker

- Pathway: 510(k) (Special)
- Applicant: Carbon Medical Technologies
- Decided: Jul 29, 2019 after 26 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: 7 generations back to K935844 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 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) Summary page 5.
- K132064: Biomarc Fiducial Marker, Carbon Medical Technologies, Inc. (2014) Summary page 5.
- K132708: Biomarc Fiducial Marker, Carbon Medical Technologies, Inc. (2013) Summary page 5.

## Indications for use
The BiomarC 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/K191797
Methodology: https://510kreport.com/methodology