# K142064: Galileo NT

- Pathway: 510(k) (Traditional)
- Applicant: Eb Neuro S.P.A.
- Decided: Feb 13, 2015 after 198 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K874685 (1988). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991054: Bravo Multi-Modality System, Nicolet Biomedical, Inc. (1999) Summary page 5.
- K073415: Nemus System; Nemus PC Peripheral, Eb Neuro S.P.A. (2008) Summary page 5.
- K012976: Twin Plus, Grass-Telefactor Divison (2002) Summary page 5.

## Most influential descendants
- K242832: NExT Station; NExT Station Advanced (2024), 0 descendants of its own
- K242305: BE Plus PRO, Neurotravel LIGHT (2024), 0 descendants of its own

## Indications for use
The GALILEO NT Line software is intended to record and display EEG, PSG, EMG and EP data acquired from the patient body through EBNeuro proprietary, FDA cleared, Acquisition Platform.(BE Plus LTM K121986, BE micro K093728, Nemus 2 system K133517.) The device is intended to be used in the clinical and hospital environment (including the hospital room, emergency room, intensive care unit, neuro-intensive care unit, critical care unit) to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles

Source page: https://510kreport.com/device/K142064
Methodology: https://510kreport.com/methodology