# K060967: Niobe Magnetic Navigation System W/Navigant Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Oct 19, 2006 after 195 days
- Product code: NDQ (System, Catheter Or Guidewire, Steerable (Magnetic))
- 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
No predicates in its family tree.
56 later devices descend from it; 4 cite it directly.
5 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stereotaxis Guidewire: named in the summary without a submission number
- (no number) Stereotaxis Telstar® Magnetic Navigation System [MNS]: named in the summary without a submission number
- (no number) Navigant TM Navigation Workstation [2.1] [NWS2]: named in the summary without a submission number
- (no number) Stereotaxis Niobe® Magnetic Navigation System: named in the summary without a submission number

## Most influential descendants
- K120550: Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) (2012), 31 descendants of its own
- K133916: Carto 3 EP Navigation System, Version 4.2 (2014), 27 descendants of its own
- K170600: CARTO 3 EP Navigation System, Version 6.0 and Accessories (2017), 20 descendants of its own
- K180238: CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT (2018), 19 descendants of its own
- K191660: CARTO 3 EP Navigation System, Version 7.1 and Accessories (2019), 16 descendants of its own

## Indications for use
The Niobe® MNS with NavigantTM NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.

Source page: https://510kreport.com/device/K060967
Methodology: https://510kreport.com/methodology