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510(k) Data Aggregation
K Number
K240420Device Name
NeuroField Analysis Suite
Manufacturer
NeuroField Inc.
Date Cleared
2024-09-20
(220 days)
Product Code
OLU, GWJ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
NeuroField Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeuroField Analysis Suite is to be used by qualified clinical professionals for the display and storage of electrical activity of a patient's brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and event-related potentials (ERP).
Device Description
The NeuroField Analysis Suite is a Normalizing Quantitative Electroencephalograph (QEEG) Software that can (1) execute EEG analysis and (2) conduct ERP test and ERP analysis. The NeuroField Analysis Suite is Software as a Medical Device (SaMD). The NeuroField Analysis Suite consists of two modules, the NF EEG Analysis Module and the NF ERP Module. The NF EEG Analysis Module is a separate analysis module that integrates with the Q21 EEG system by adding "Analysis", "Report", and "Tools" menu items and toolbars. It performs real-time and offline analysis functions and displays analysis results in separate windows in the UI, which can be accessed via the "Analysis" and "Reports" menu items. The NF ERP Module is a separate evoked response potential (ERP) module that can control and get data from the Q21 EEG system and performs typical ERP functions like stimulus presentation, EEG epoching, epoch averaging, reaction time, and ERP display. The NF ERP Module is a separate stand-alone application.
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K Number
K221959Device Name
Q21
Manufacturer
NeuroField Inc.
Date Cleared
2023-08-31
(422 days)
Product Code
GWQ, GWO
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
NeuroField Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeuroField Q21 System is indicated for prescription use to acquire, record, transmit, and display physiological data for electroencephalographic (EEG) studies of patients of all ages.
Device Description
The Q21 is a 20-Channel Quantitative Electroencephalogram (QEEG) system which records 24-bit high resolution EEG data. NeuroField EEG is the main software which runs on a Windows-based computer/laptop where basic data is collected and controls the Q21. This software records the patient information and displays and stores the EEG. The Q21 system provides for typical EEG functions, including realtime EEG recording and viewing, adjustable vertical and horizontal display scale, adjustable highpass, lowpass, and notch filters, file import and export, offline review, the ability to show and hide individual channels, remontaging, and the ability to add event markers. The Q21 system supports both individual electrodes and standard 19-channel Electrocap electrode arrays. Each Q21 system consists of an amplifier, software, and components of a standard personal computer (monitor, keyboard, and mouse). The Q21 amplifier is a 19+1 channel, 24-bit, low-noise, non-multiplexed, battery-powered, optically-isolated amplifier. The "+1" channel can be used as an auxiliary physiological channel.
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