# K171581: Neuro Omega System

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Omega Engineering, Ltd.
- Decided: Dec 22, 2017 after 205 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
Longest line of descent: 2 generations back to K924226 (1993). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123796: Neuro Omega System, Alpha Omega Engineering, Ltd. (2013) Summary page 4.
- K072964: Nicolet Cortical Stimulator, Cardinal Health, Inc. (2008) 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

## 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 subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage 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 subject device, the Neuro Omega System incorporated the installed HaGuide software 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). -To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG). -To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. -To provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder. The device is intended for intraoperative use by medical personnel. Within hospitals, 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/K171581
Methodology: https://510kreport.com/methodology