Device
NeuroMatch is a Software as Medical Device intended for physicians to review EEG data.
Manufacturer
LVIS CORPORATION
LVIS CORPORATION
Model: 1.0.7
DI: 00850056774017
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
NeuroMatch is a Software as Medical Device intended for physicians to review EEG data.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c71186fd-17d4-4c86-a8b3-cc4bd8cdb69f
Distribution Status:
In Commercial Distribution
DUNS Number:
079120302
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850056774017
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 67670
Name: Electroencephalographic diagnosis-support software
Definition:
A software program intended to acquire and process neurological physiological parameter data [primarily electroencephalographic (EEG)] to assist a healthcare professional in the diagnosis of neurological conditions. It has a general-purpose neurological use and is not dedicated to, e.g., sleep monitoring, psychiatric analysis, or seizure-detection.
FDA Product Codes
OMB
Automatic Event Detection Software For Full-Montage Electroencephalograph
OLT
Non-Normalizing Quantitative Electroencephalograph Software
OMA
Amplitude-Integrated Electroencephalograph
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Premarket Submissions
Item #1 - Submission Number:
K222450
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K241390
Item #2 - Supplement Number:
000
Item #3 - Submission Number:
K250239
Item #3 - Supplement Number:
000