Quex S
QUEX S is an electrophysiological system that records two channel EEG and galvanic skin response signals. It is intended for trained healthcare professionals in clinical facilities, with…
QUEX S is an electrophysiological system that records two channel EEG and galvanic skin response signals. It is intended for trained healthcare professionals in clinical facilities, with signals displayed through QUEX Monitor software on a Windows computer.
Dry forehead electrodes record brain activity, while wrist and ankle electrodes measure changes in skin conductance associated with sweat gland activity. The hardware amplifies and digitizes the electrode signals before transfer to the computer by USB.
Listed Item
The QUEX S device is an electrophysiological system with EEG and GSR functions. The main related components are identified as follows: QUEX Monitor software (version 1.0.0.10) and QUEX S Hardware V 1.4.2.
Recording and Interpretation
EEG signals can be stored and viewed in real time to assist professional neurological assessment. The system does not generate a diagnostic conclusion or automated alerts for adverse clinical events. Its GSR function detects and monitors skin electrical conductance.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | QX World KFT, Hungary |
|---|---|
| FDA product code | OMC |
| Device type | Reduced- Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Manufacturer |
| 510(k) | K232779 |
| Record published | 2026-04-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| System | In distribution | |
| Hardware V1.4.2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X-Series | Advanced Brain Monitoring, Inc. | 59 |
| Sleep Profiler PSG2 | Advanced Brain Monitoring, Inc. | 22 |
| Sleep Profiler | Advanced Brain Monitoring, Inc. | 13 |
| Remi | Epitel | 12 |
| Natus | Xltek | 5 |
| Narcotrend Patient lead | MT Monitortechnik Gmbh & Co. KG | 2 |
| Reduced- Montage Standard Electroencephalograph | GE Healthcare Finland OY | 2 |
| AE-120A EEG Head Set | Nihon Kohden Corp. | 2 |
| VitalEEG Portable System | Nihon Kohden America, Inc. | 2 |
| Nurochek-Pro | Headsafe MFG PTY Ltd | 2 |
| Quex ED | QX World KFT | 2 |
| Global Reference Module 4 | Neuralynx, Inc. | 1 |
Showing 12 of 87. All products under Reduced- Montage Standard Electroencephalograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232779 | 2024-10-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.