# K013419: Nicolet Electromagnetic Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Nicolet Biomedical
- Decided: Dec 20, 2001 after 66 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K041897: Mayfield Acciss II Image Guided Surgery System, Model 2002-01 (2005), 0 descendants of its own

## Indications for use
The NEN provides intra-operative image guidance during neurosurgical operations. It provides support to the surgeon during data preparation and provides feedback concerning actions performed and parameters set. It is not intended as a diagnostic device. The ultimate responsibility for how and where the surgical operation is conducted is the responsibility of the surgeon. The device is to be used by or on order of a physician.

Source page: https://510kreport.com/device/K013419
Methodology: https://510kreport.com/methodology