# K222832: Sentimag System

- Pathway: 510(k) (Traditional)
- Applicant: Endomagnetics Ltd.,
- Decided: Jan 21, 2023 after 123 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: 10 generations back to K023694 (2003). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153044: Sentimag System, Sentimark Magnetic Marker Systerm, Endomagnetics Ltd., (2016) Summary page 4.
- K173587: Magseed Magnetic Marker Systtem, Endomagnetics Ltd., (2018) Summary page 4.
- K163541: Magseed Magnetic Marker System, Endomagnetics Ltd., (2017) Summary page 4.

## Indications for use
The Sentimag Magnetic Localization System when used with the Magseed® marker is indicated to assist in localizing soft tissue lesions. The Endomag Sentimag System is the only non-imaging guidance system intended for use with the Magseed® magnetic marker.

Source page: https://510kreport.com/device/K222832
Methodology: https://510kreport.com/methodology