# K180443: Tumark Vision

- Pathway: 510(k) (Special)
- Applicant: Somatex Medical Technologies GmbH
- Decided: Mar 22, 2018 after 30 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- 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 K970817 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560, Somatex Medical Technologies GmbH (2010) Summary page 5.

## Indications for use
The Tumark Vision is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. It is indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not intended to be used with magnetic resonance imaging (MRI) techniques.

Source page: https://510kreport.com/device/K180443
Methodology: https://510kreport.com/methodology