# K190155: FibermarX Radiopaque Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Viscus Biologics, LLC
- Decided: Feb 27, 2019 after 28 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: 1 generation back to K071614 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071614: Fiducial Markers, Civco (2007) Summary page 4.

## Indications for use
FibermarXTM Radiopaque Tissue Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. In addition, the markers are indicated in situations where tissue needs to be marked for future medical procedures such as IMRT/IGRT.

Source page: https://510kreport.com/device/K190155
Methodology: https://510kreport.com/methodology