# K133995: Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software

- Pathway: 510(k) (Traditional)
- Applicant: Neurosoft, Ltd.
- Decided: Jun 19, 2015 after 540 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: 8 generations back to K884937 (1989). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122196: Cervello Bio-Potential Signal Acquistion System Product Family, Blackrock Neuromed, LLC (2013) Summary page 5.
- K132306: Persyst 12 Eeg Review and Analysis Software, Persyst Development Corp. (2013) Summary page 5.
- K040595: ALICE 5, Respironics, Inc. (2004) Summary page 5.
- K102610: Focus Emg Device, Teleemg, LLC USA (2011) Summary page 5.
- K011204: Neurofax, Models Eeg-1100A, Eeg-9100A, Nihon Kohden America, Inc. (2001) Summary page 5.

## Most influential descendants
- K220254: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (2022), 0 descendants of its own

## Indications for use
The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG),1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P). Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes.

Source page: https://510kreport.com/device/K133995
Methodology: https://510kreport.com/methodology