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The Flexset system is intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Flexset system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals and video.

The Flexset System is intended to acquire, transmit, display and store primarily EEG and optionally auxiliary signals. Specific transport environments in the Indications for Use include ambulances, cars, buses, trains, boats and via air, per stipulation in the user manual of the device. The Flexset headset is designed to record a full montage EEG, with optional external references and additionally up to 8 auxiliary channels using lead wires for EEG, EOG, ECG or EMG. The device consists of the following components: - Flexset (Headset) . - Electrodes - Charger with cable ● - Display Unit ● - Extension Unit ● - Lead wires ● - Software ● - Display Unit firmware o - Data center application (same as K172735) O - O Client application (same as K172735)

The Neuronaute Plus is a system intended to acquire, store, archive, and periodically transmit physiological signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the BioSerenity Cloud. The Neuronaute Plus and its associated software are intended to assist in the diagnosis of neurological disorders. The Neuronaute Plus and its components do not provide any diagnostic conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The Neuronaute Plus is intended to be used by trained healthcare professionals, technicians or patients above 15 years old. In case of a patient below 15 years old, Neuronaute Plus is intended to be used by a care giver. Adequate training is recommended for proper use of the device. Neuronaute IceCap 2 electrodes are able to be used on patients weighing at least 10 kg and having a head circumference above 43 cm. Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis. The BioSerenity Cloud allows the display of signals in the diagnosis of physiological disorders through the data collected by recording. The BioSerenity Cloud should allow the analysis and filtering of data in order to aid doctors in diagnosing neurological disorders.

The Neuronaute Plus is a non-invasive medical device which enables the acquisition, recording, storage and transmission of electrophysiological signals in order to analyze potential neurological disorders. The system is composed of the pieces of equipment listed below, and the Neuronaute Plus components are connected through Bluetooth and Wi-Fi. - -Neuronaute Plus (Core module): is a signal acquisition system: an electronical amplifier that records EEG, ECG, EMG, EOG and breathing signals via a connection to EEG caps which transmits the data to the Neuronaute mobile application and Cloud system. - -Neuronaute Plus IceCap extender : is a removable interface to connect the signal acquisition system to the IceCap and IceCap2 & 2 Small. - -Neuronaute Plus DB25 Extender : is a removable interface that can connect the signal acquisition system to any DB25-compatible EEG cap. - -Holding band : is a wearable textile band which allows the patient to place the Neuronaute Plus close around his chest over clothes. the use of the holding band is optional. - -Neuronaute IceCap: is a single use 21 electrode headset that connects to the Neuronaute Head Module via the IceAdapter, the DB25 cable and the Neuronaute BioAdapter, or Neuronaute Plus with its IceCap Extender. Recently, the Neuronaute Touchproof Adapter was developed to connect the IceCap electrode to Neuronaute Head module via a touchproof channel. - Neuronaute IceCap 2 & 2 Small: recently cleared version of the IceCap dedicated to adults and pediatric patients. It connects similarly to Neuronaute and Neuronaute Plus. - Neuronaute Mobile APP: is compatible with iOS systems. The mobile application enables the healthcare professionals to access and manage the prescribed recording sessions. - -Bioserenity CLOUD: is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals. The physician, who prescribes the use of this device, should monitor its use and confirm the proper functioning of signal recording through the Neuronaute Cloud. - -VEEG pack: it is composed of the Neuronaute N-DEO and Neuronaute N-WAY. The Neuronaute N- DEO camera enables the visualization of the patient during a recording. The IP camera provides HD resolution video sequence at 1080p, with advanced night mode and WDR technology. The Neuronaute N- WAY enables wireless connectivity (4G) for remote monitoring and data transmission to the cloud platform.

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.

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.

The SPARK Scan is intended to acquire, display, and store the electrical activity of a patient's brain obtained by placing two or more electrodes on the head to aid in diagnosis.

The SPARK Scan is intended for the acquisition, display, and storage of electroencephalogram (EEG) data. The SPARK Scan is intended to be used by EEG technicians, or appropriately trained Nurses and Medical Assistants practicing in any medical setting where EEG data collection may be required. The SPARK Scan is an SaMD product that consists of the Edge Software and Data Storage and Communication Platform. The Edge software runs locally on the user's device and consists of a User interface and the EEG hardware interface, including the electroconductive gel (K1117). The User Interface is a desktop application that (a) manages interaction with the EEG hardware interface, (b) facilitates set up and recording of EEG data, and (c) provides limited access to review of patient records according to the user's permissions. The Data Storage and Communication Platform (Cloud Software): The Cloud software runs on a server managed by SPARK Neuro and contains no user interface. The Cloud Software is responsible only for managing (a) authorization and authentication of users and (b) storage, validation, and access to all data collected on the system. The SPARK Scan is compatible with three 3rd-party accessory devices: an FDA-cleared EEG hardware system, a standard off-the-shelf-laptop, and FDA-cleared EEG Recording Viewing Platforms.

The Cumulus Functional Neurophysiology Platform is intended for the acquisition, display and storage of electroencephalograph (EEG) obtained by placing electrodes on the head of adults and adolescent patients. The EEG signals are time-stamped. The system can be used in the patient's home or a health care facility.

The Cumulus Functional Neurophysiology Platform is comprised of the Cumulus Headset which records EEG signals that are time-stamped. The Cumulus software application runs on a mobile device running android software. The software has graphical user interface that provides guidance to the user to place the headset correctly. The EEG data is received from the headset via Bluetooth. The data received is synchronised and timestamped between the headset and app. The Cumulus Medical Device Hub provides the user interface for health care professionals to view, download and review data from the recordings. The Platform components are: • Cumulus EEG Headset with embedded software, which includes: • An adjustable shell into which 16 Ag/AgCl EEG conductive sensors are attached. • A zippered pocket for holding the detachable electronics. • Interface buttons, LEDs, micro USB socket. • Plastic-encased 'Puck' electronics. • Cumulus Mobile device with installed Cumulus Mobile App. • Disposable mastoid sticky sensors • Earphones • Device stand • Headset and mobile device chargers Patient contacting materials are biocompatible, commercially sourced and are used in the headset without modifications. The device and accessories are not sterile, nor intended to be sterilized.

The Okti System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various neurological disorders. The Okti is designed for use in a hospital or other clinical environment. The Okti is only to be used under the direction of a physician.

The Okti is a physiological data acquisition device intended for conducting EEG studies. It is used in conjunction with a PC running Compumedics Profusion EEG software. Power is provided by either an internal Lithium-Ion battery or a POE 100BASE-TX network connection. Physically, the Okti comprises a base unit housing the battery and digital electronic circuits. A changeable module connects to the base unit and houses the analogue circuity and electrode connectors providing options for 32, 64 or 128 referential, or single ended, channels primarily intended for EEG. Each module includes several differential inputs for electrode-based signals such as ECG, EMG or EOG. All these inputs are class CF for patient safety. Patient physiological data is digitised using multiple 24-bit ADCs and filtered using fixed point FIR filters implemented internally to an FPGA located in the analogue module. The data is transferred to a generalpurpose processor in the base unit over a synchronous serial link. From there the patient data may be saved to a device internal SD card or sent to a remote PC over an Ethernet or Wi-Fi LAN connection. A Bluetooth interface is also included for connection to external devices such as an oximeter. The Okti system is available in Okti32, Okti64, or Okti128. These differ only in channel number.

Neuronaute with IceCap 2 & IceCap 2 Small is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults and pediatrics. Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone but should be used along with all other clinical data and exams to come to a diagnosis.

Neuronaute with IceCap 2 & IceCap 2 Small is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array. The system includes the Neuronaute Head Module, IceCap 2 & IceCap 2 Small electrodes, battery, Bioadapter with the IceAdapter, mobile app, and the Neuronaute N-CLOUD. The IceCap 2 and IceCap 2 Small are single-piece flexible printed circuit headsets with 21 EEG sensors (19 EEG channels, 1 reference and 1 ground), 4 skin adhesive areas and 2 connectors. The electrodes are made of Ag/AgCl sensors connected via conductive silver ink and insulated with dielectric ink. The system allows remote access by users via the Neuronaute N-CLOUD. An optional video system composed by N-way and N-Deo is available.

The iSyncWave is intended for prescription use in a health care facility to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.

iSyncWave™ is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset. iSyncWave™ measures 19 channel EEG in real time and transfers the data through BLE wireless connection to the iSyncWave™ App. The data is displayed and recorded via the iSyncWave™ App. iSyncWave™ uses dry electrode technology, which doesn't require a preparation process(e.g., applyinq conductive gel), to obtain high quality EEG signals. Before measuring the EEG, you can check the impedance of each electrode under the impedance check screen in the iSyncWave™ app. An EEG amplifier, analog-to-digital converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and then converted to digital data at 24-bit resolution. This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and 1 ground electrode. The measured data can be digitally converted to common average, longitudinal and transverse montage. The measured data is automatically uploaded to a secure cloud server via Wi-Fi connection and saved securely. The data saved in the cloud server can be seen on the iSyncWave™ app.

The electroencephalographic system Seer Home is intended to acquire, display, and store the electro-physiological signals of the patient's brain obtained by placing electrodes on the patient scalp. The Seer Home is intended to be used for such studies as electroencephalograph (EEG) and video EEG recording to aid in diagnosis of neurological disorders. The Seer Home does not draw any diagnostic conclusions. Seer Home is not intended for use as life support equipment such as vital signs monitoring in intensive care units. Seer Home is only to be used under the direction and supervision or EEG technologist or clinician.

The Seer Medical - Seer Home is an ambulatory electroencephalograph system designed to be used at the patient's home for up to week-long studies. The ambulatory EEG recorder (called "Seer Sense" or "Wearable") is worn around the patient shoulders. The Wearable has a single cable exiting from the bottom of the device and is routed inline to 3 disposable ECG electrodes which are positioned on the chest for ECG recording. Exiting from the rear of the Wearable is single flexible cable which has a junction at the top of the patient's head connected to the 22 EEG electrodes (disposable) which are positioned in the international '10-20' system for EEG recording. The Wearable records the EEG and ECG signals and wirelessly transmits them to a nearby "Seer Sight Video Monitoring Hub" in the patient's house. The Video Monitoring Hub has two roles, first to store the wireless data from the wearable, and the second is to record video from an in-built camera that is synchronized to the EEG/ECG data. The use of the recorded video data provides additional information to the physician (such as body movement artifacts) to assist in diagnosis in the neurological conditions. At the end of the study period (up to a week) the Wearable and Hub are returned back to the clinic for data download. The Seer Cloud Platform software downloads the data, stores the data, displays the EEG/ECG signals and video for reviewers to interpret, make annotations, and produce reports. The Seer Home is intended to be used by qualified operators or physicians trained in the interpretation of EEG/ECG signals and visual cues of patient movements - and is viewed as a part of a range of assessments used by Neurologists to assist in making diagnosis of neurological conditions. The accessories used with the Seer Home are disposable EEG electrodes, disposable ECG electrodes, Transport/Carry case, Medical Grade Power Adapter, IFU, and Rechargeable Batteries.

WAV SCAN EEG System is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.

WAVi™ SCAN EEG system (WAVi™ SCAN 1.0) is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and eventrelated potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. The medical system includes the "WAVi™ EPU" (Electronic Processing Unit), an EEG amplifier intended to be used with EEG accessories cleared in K162460 and a computer (laptop computer or tablet device with internal battery and power cord). The hardware and ancillary components used in conjunction with WAVI™ SCAN 1.0 include an EEG cap, the WAVI™ EPU, headphones, a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device programming. The WAVI EEG System's software includes electronic versions of standardized clinical assessment tools related to psychiatry and neuropsychological evaluation but are provided for convenience and are to be used in accordance with the assessment tools' specific general instructions. These tools do not interact with any other of the EEG system's hardware and software measures and are stand alone.