# K022326: Radiomed Marker

- Pathway: 510(k) (Traditional)
- Applicant: Radiomed Corporation
- Decided: Jan 31, 2003 after 197 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K874787 (1987). 7 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983400: Auto Suture Site Marker Clip, United States Surgical, A Division of Tyco Healthc (1999) Summary page 1.
- K000060: Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007, Senorx, Inc. (2000)
- K013660: Genetra, Radiomed Corporation (2001)

## Most influential descendants
- K031206: Radiomed Soft Tissue Marker (2003), 20 descendants of its own
- K070305: Pre-Loaded Visicoil (2007), 11 descendants of its own
- K080726: Calypso 4D Localization System (2008), 9 descendants of its own
- K102373: Calypso System with Dynamic Edge Gating (2010), 6 descendants of its own
- K112768: Calypso Systems with Dynamic Edge Gating (2011), 4 descendants of its own

## Indications for use
RadioMedTMMarker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

Source page: https://510kreport.com/device/K022326
Methodology: https://510kreport.com/methodology