# K172042: NeuroNav System, NeuroSmart System

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Omega Engineering, Ltd.
- Decided: Feb 27, 2018 after 236 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 K071697 (2007). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071697: Neuronav System and Neuronav Drive, Alpha Omega, Ltd. (2007) Summary page 4.

## Most influential descendants
- K220553: Neuro Omega System, NeuroSmart System (2022), 1 descendant of its own
- K250601: Neuro Omega System; NeuroSmart System (2025), 0 descendants of its own

## Indications for use
The NeuroNav System / NeuroSmart System, incorporated the installed HaGuide software, is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrode. The NeuroNav Drive is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of depth electrodes.

Source page: https://510kreport.com/device/K172042
Methodology: https://510kreport.com/methodology