# K070305: Pre-Loaded Visicoil

- Pathway: 510(k) (Special)
- Applicant: Radiomed Corporation
- Decided: Mar 7, 2007 after 34 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: 5 generations back to K874787 (1987). 10 ancestors in all.
11 later devices descend from it; 6 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031206: Radiomed Soft Tissue Marker, Radiomed Corp. (2003) Summary page 1.
- (no number) 17, 18, 19g needles manufactured by CP Medical: named in the summary without a submission number

## Most influential descendants
- K091645: Gold Anchor (2009), 3 descendants of its own
- K071673: Onc Solutions Marker, Models 001001 to 001012 and 001021 to 001032 (2007), 3 descendants of its own
- K160209: Gold Anchor (2016), 2 descendants of its own
- K140823: Permanent Beacon Transponder/Soft Tissue Beacon Transponder (2014), 2 descendants of its own
- K201117: Gold Anchor (2020), 1 descendant of its own

## Indications for use
Pre-Loaded VisiCoil is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

Source page: https://510kreport.com/device/K070305
Methodology: https://510kreport.com/methodology