# K220254: Neuron-Spectrum-AM with Neuron-Spectrum.NET Software

- Pathway: 510(k) (Traditional)
- Applicant: Neurosoft, Ltd.
- Decided: Nov 30, 2022 after 303 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: 9 generations back to K884937 (1989). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133995: Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software, Neurosoft, Ltd. (2015) Summary page 4.

## Indications for use
The Neuron-Spectrum-AM system with Neuron-Spectrum.NET software is intended for use as a digital neurophysiological system for recording, processing, and displaying biopotential signals such as Electroencephalography (EEG) and Polysomnography (PSG) derived from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The device is portable and can register up to 21 EEG channels, 4 polygraphic channels, 1 breath channel, and 1 direct current channel. The device does not provide alarms, does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories, and sleep laboratories. The device can also be used as a home use device under supervision of qualified personnel. The patient group includes all ages and sexes.

Source page: https://510kreport.com/device/K220254
Methodology: https://510kreport.com/methodology