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510(k) Data Aggregation
K Number
K232779Device Name
QUEX ED; QUEX S
Manufacturer
QX World Ltd
Date Cleared
2024-10-11
(396 days)
Product Code
OMC, GZO
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
QX World Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QUEX ED and QUEX S device is indicated for use as an Electrophysiological System. The Electrophysiological System is made up of the following Items which are functions of the QUEX ED and S device:
1. Two channel EEG:
The QUEX ED and S Device is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visual signals assist trained medical staff to make neurological diagnoses. The EEG device does not provide any diagnoses conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The QUEX ED AND S Device is intended to be used in a professional healthcare facility environment.
2. GSR [galvanic skin response measuring]
The QUEX ED and S device is intended for use by trained healthcare professionals, to detect and monitor electrical signals produced by the body skin conductance by using electrodes placed on the skin.
Device Description
QUEX ED or QUEX S devices are contains the following components:
- QUEX ED or QUEX S hardware.
- I QUEX Monitor software
- . USB - USB cable for data communication and power supply.
- EEG electrodes (head electrodes)
- Electrodes for GSR measurements (limbs)
- I Cable harnesses for head and limbs.
The QUEX Monitor software is exclusively used for QUEX ED or QUEX S as part of the system.
The EEG electrodes and the electrodes used for GSR measurements are connected to the QUEX ED or S devices. The device makes the necessary gain on the analog signals and digitalize the signals. The digitalized information is acquired and displayed by the QUEX Monitor software. The QUEX monitor software can run on PCs, notebooks with Windows OS.
Electroencephalography (EEG), measures brain wave activity. The system uses the head harness and electrodes to acquire the signals. The QUEX Devices are measures brain activity on two channels. The EEG wave recording electrodes are connected to the forehead with dry electrodes.
The galvanic skin response (GSR, which falls under the umbrella term of electrodermal activity, or EDA) refers to changes in sweat gland activity.
The GSR recording is done via limb electrodes attached to the wrists and ankles.
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