# K251792: Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Nov 6, 2025 after 148 days
- Product code: DXX (System, Catheter Control, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1290
- 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 K900765 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021555: Stereotaxis Niobe Magnetic Navigation System, Stereotaxis, Inc. (2003) Summary page 5.

## Most influential descendants
- K262744: GenesisX RMN (2026), 0 descendants of its own

## Indications for use
The GenesisX RMN is intended to navigate compatible magnetic devices in the chambers of the heart and arterial and venous vasculature by orienting the device tip in a desired direction.

Source page: https://510kreport.com/device/K251792
Methodology: https://510kreport.com/methodology