# K250601: Neuro Omega System; NeuroSmart System

- Pathway: 510(k) (Special)
- Applicant: Alpha Omega Engineering, Ltd.
- Decided: Mar 30, 2025 after 30 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: 4 generations back to K924226 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220553: Neuro Omega System, NeuroSmart System, Alpha Omega Engineering, Ltd. (2022) Summary page 6.

## Indications for use
Neuro Omega System: The Neuro Omega System with the incorporated 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 Neuro Omega System with the incorporated 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 a seizure disorder. The Neuro Omega System with the incorporated installed HaGuide Software, is intended for intraoperative use by medical personnel. Within hospitals, laboratories, clinics, or nursing home settings or outside of a medical facility under the direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording. NeuroSmart System: The NeuroSmart System with the incorporated HaGuide Software, is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes

Source page: https://510kreport.com/device/K250601
Methodology: https://510kreport.com/methodology