# K250239: NeuroMatch

- Pathway: 510(k) (Traditional)
- Applicant: LVIS Corporation
- Decided: May 23, 2025 after 116 days
- Product code: OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph)
- 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: 3 generations back to K002631 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172858: PreOp, Epilog (2018) Summary page 6.

## Indications for use
1. LVIS NeuroMatch Software is intended for the review, monitoring and analysis of electroencephalogram (EEG) recordings made by EEG devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information. 2. The Seizure Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients greater than or equal to 18 years old that may correspond to electrographic seizures, in order to assist qualified medical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the electrodes from the International Standard 10-20 placement. 3. The Spike Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients ≥18 years old that may correspond to spikes, in order to assist qualified medical practitioners in the assessment of EEG traces. LVIS NeuroMatch Spike Detection performance has not been assessed for intracranial recordings. 4. LVIS NeuroMatch includes the calculation and display of a set of quantitative measures intended to monitor and analyze EEG waveforms. These include Artifact Strength, Asymmetry Spectrogram, Autocorrelation Spectrogram, and Fast Fourier Transform (FFT) Spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. 5. LVIS NeuroMatch displays physiological signals such as electrocardiogram (ECG/EKG) if it is provided in the EEG recording. 6. The aEEG functionality included in LVIS NeuroMatch is intended to monitor the state of the brain. 7. LVIS NeuroMatch Artifact Reduction (AR) is intended to reduce muscle and eye movements, in EEG signals from the International Standard 10-20 placement. AR does not remove the entire artifact signal and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifacts, and any interpretation or diagnosis must be made with reference to the original waveforms. 8. LVIS NeuroMatch EEG source localization visualizes brain electrical activity on a 3D idealized head model. LVIS NeuroMatch source localization additionally calculates and displays summary trends based on source localization findings over time. 9. This device does not provide any diagnostic conclusion about the patient’s condition to the user.

Source page: https://510kreport.com/device/K250239
Methodology: https://510kreport.com/methodology