# K031206: Radiomed Soft Tissue Marker

- Pathway: 510(k) (Special)
- Applicant: Radiomed Corp.
- Decided: May 21, 2003 after 35 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: 4 generations back to K874787 (1987). 9 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022326: Radiomed Marker, Radiomed Corporation (2003)
- K940121: Implanters/Adjustable/Anderson's Markers, Best Industries (1994) Summary page 1.
- (no number) Extracranial Marker: named in the summary without a submission number

## Most influential descendants
- 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
- K123137: Calypso System (2012), 3 descendants of its own

## Indications for use
RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

Source page: https://510kreport.com/device/K031206
Methodology: https://510kreport.com/methodology