# K993622: Neurotrek Physiological Navigation System for Neurosurgery

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Omega, Ltd.
- Decided: Jan 24, 2000 after 90 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970943 (1997). 2 ancestors in all.
4 later devices descend 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)
- K970943: Guideline System, Axon Instruments, Inc. (1997) Summary page 2.
- K981820: Neuromap, Radionics, Inc. (1998) Summary page 2.

## Most influential descendants
- K071364: Microtargeting Guideline 4000 (2007), 3 descendants of its own
- K183123: microTargeting Guideline 4000 5.0 System (2018), 1 descendant of its own
- K250094: Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (2025), 0 descendants of its own
- K140680: Leadpoint Focus Workststion, Leadpoint Focus Notebook System (2014), 0 descendants of its own

## Indications for use
Alpha Omega NeuroTrek system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrode.

Source page: https://510kreport.com/device/K993622
Methodology: https://510kreport.com/methodology