# K123796: Neuro Omega System

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Omega Engineering, Ltd.
- Decided: Apr 5, 2013 after 116 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
2 of 4 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
- K171581: Neuro Omega System (2017), 2 descendants of its own
- K220553: Neuro Omega System, NeuroSmart System (2022), 1 descendant of its own
- K250601: Neuro Omega System; NeuroSmart System (2025), 0 descendants of its own

## Recalls of this device
- Sep 4, 2018 · Class I · Z-1216-2019: If cables are improperly connected, current may reach high charge density, causing tissue harm.

## Indications for use
The Neuro Omega System, including the NeuroDrive unit, is intended to assist 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 electrodes. The Neuro Omega System is also intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG). The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.

Source page: https://510kreport.com/device/K123796
Methodology: https://510kreport.com/methodology