# K173251: LumiCoil Platinum Fiducial Marker

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Dec 19, 2017 after 70 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 K874787 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070305: Pre-Loaded Visicoil, Radiomed Corporation (2007) Summary page 5.
- K161724: Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded), Radiomed Corporation (2017) Summary page 5.

## Indications for use
The LumiCoil Platinum Fiducial Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

Source page: https://510kreport.com/device/K173251
Methodology: https://510kreport.com/methodology