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510(k) Data Aggregation
K Number
K240575Device Name
WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
Manufacturer
eemagine Medical Imaging Solutions GmbH
Date Cleared
2024-11-25
(269 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
eemagine Medical Imaging Solutions GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is an EEG electrode set intended for routine clinical settings where rapid placement of a large number of EEG electrodes is desired. Patient population from infants up to any age.
Device Description
WaveGuard™ Net EEG cap consists of Saline-based EEG electrolyte- soaked sponge electrodes made of PU substrate plated with Ag and arranged in Chin-strap (placed under the chin). Cable bundle(s) with connector(s) The layout of the electrodes depends on the number of electrodes placed in the cap, and may be placed according to the international 10/10, 10/20 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from baby to large adult head-size, spanning a total of 6 different cap sizes.
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K Number
K210109Device Name
visor2 system
Manufacturer
Eemagine Medical Imaging Solutions GmbH
Date Cleared
2022-04-08
(444 days)
Product Code
HAW, GWF, IKN, OBP
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Eemagine Medical Imaging Solutions GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on data from MRI measurements or scalp landmarks and optional EMG recording in clinical procedures. The visor2 system is compatible with the following commercially available TMS coils of the following TMS companies:
- · Mag & More: PMD70-aCool Double coil Figure-8 (510575)
- MagStim Company Ltd.: Double 70mm Remote Coil (3190-00 rev2), Double 70mm Air Film Coil (3910 00);
- MagVenture A/S: Double 75mm (C-B60), Double Cooled 75mm (Cool-B65), Double 95mm (D-B80), Angulated Double Cooled 97mm (Cool-B70 rev2), Butterfly figure-8 (C-B70)
- · Neuronetics Inc .: NeuroStar coil
The visor2 system must be operated by a trained physician and must not be used during surgical operations.
Device Description
The visor2 system is a 3D navigation system, supporting external/surface positioning of labeling identified commercially available Transcranial Magnetic Stimulation (TMS) coils based on the anatomical and functional areas for which use of the coil has been FDA cleared and as identified in cleared labeling for the coil. The visor2 system optionally records and processes electrophysiological signals to guide the user in the TMS coil placement. The visor2 system is compatible with TMS stimulators identified in the labeling that meet IEC 60601-1 and IEC 60601-1-2 electrical safety and EMC standards, a compatible optical tracking system, and further compatible accessories. Optionally, a compatible amplifier identified in the labeling may be applied for measuring electrophysiological signals. The visor2 system must be operated by a trained physician, and must not be used during surgical operations.
The visor2 system consists of a cart, an All-in-One medical computer with touch interface, a mounting plate for an optional amplifier applied for EMG recording and a Tracking camera with mounting arm. There are two fundamental visor2 system variants: single or dual display. the second configuration is available with an additional touch display added next to the All-in-One computer. Both variants are identical with regard to hardware features.
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K Number
K192889Device Name
Neo
Manufacturer
eemagine Medical Imaging Solutions GmbH
Date Cleared
2020-01-30
(112 days)
Product Code
OMA, OMC, ORT
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
eemagine Medical Imaging Solutions GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The neo monitor is an 8-channel electroencephalograph (EEG) acquisition software. The device is intended to record and display EEG and aEEG signals for monitoring the brain status of neonatal patients (defined as from birth to 28 days postdelivery, and corresponding to a postconceptual age of 24 to 46 weeks). The device is to be used in a hospital environment by qualified clinical practitioners. The device does not provide any diagnostic conclusion about the patient's condition to the user.
Device Description
The nëo™ system is a reduced montage neonatal electroencephalograph device that acquires, displays, stores, and archives electroencephalographic signals from the brain. By application of electrodes at specific location on the cranium,using up to 10 surface electrodes placed at specific locations the system functions to measure and record electrical activity of the brain by acquisition of electroencephalograph data and amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
The neo System is an electromedical device incorporating software. The device itself has no patient contact, but is intended for use with FDA-cleared ECG electrodes. nëo™ Monitor software, which, when installed into a compatible touchscreen PC and paired with a physiological signal amplifier (eego model EE-411) forms the nëo™ Monitor System. The system is a compact and easy-to-use and can be set on a bedside table, pole-mounted, or on a cart in the neonatal care areas.
The system, as-delivered to the customer, is comprised of:
- nëo Monitor software (pre-installed)
- 15" Panel PC
- eego EE-411 model amplifier
- Mounting plate
- nëo User Manual .
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K Number
K172312Device Name
eego amplifiers
Manufacturer
eemagine Medical Imaging Solutions GmbH
Date Cleared
2018-03-30
(241 days)
Product Code
GWL, GWQ, OMC
Regulation Number
882.1835Why did this record match?
Applicant Name (Manufacturer) :
eemagine Medical Imaging Solutions GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The eego amplifier is intended to be used by or under the direction for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems.
Device Description
The eego amplifier is a multi-channel, plastic enclosed EEG amplifier. There are two ranges for the variations of amplifiers (models):
- 1. EE-2xx, and
- 2. EE-4xx.
In total, there are 8 models. The EE-411 and EE-430 amplifiers are built using identical components and share identical internal structure, functionality and performance. The eego amplifier electroencephalography (EEG) input is from commercially available EEG electrodes from the Waveguard™ EEG Cap cleared in K110223. The eego amplifiers support EEG acquisition and storage by:
- 1. referential DC input channels,
- 2. parallel trigger input channel.
Electrode Impedance values can be measured for all referential electrodes, reference and patient ground electrode. Signal sampling rate and gain are set through the user interface of the Software Development Kit (SDK). The EE-2XX series of eego amplifier is powered by a built-in, rechargeable battery. The battery provides a minimum of 4 hours of operation time. The amplifier can be applied for data acquisition with the 12 V battery charger source applied. The USB port supports interface to the computer running the SDK. The EE-4XX series of eego amplifier is powered by the USB port connection to a computer.
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K Number
K110223Device Name
WAVEGUARD (TM) EEG CAP
Manufacturer
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
Date Cleared
2011-06-29
(155 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is an EEG electrode set intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.
Device Description
WaveGuard caps consist of Cap fabric Electrodes arranged in a certain layout Chin-strap (placed under the chin) Cable bundle(s) with connector(s) The layout of the electrodes depends on the number of electrodes placed in the cap, and may be placed according to the international 10/20, 10/10 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from neonatal size (23-weeks old) to large adult head-size, spanning a total of 11 different cap sizes.
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K Number
K070358Device Name
MAXINSIGHT
Manufacturer
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
Date Cleared
2007-07-30
(173 days)
Product Code
OLX
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The software is intended for use by a trained/qualified MEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function by fusing a variety of magnetoencephalographic (MEG) and electroencephalographic (EEG) information with rendered images of either an idealized head model and an idealized magnetic resonance (MR) image or a subject's MR image based head model and the subject's MR images
Device Description
The MaxInsight ™ software is a software-only product. It runs on a personal computer and requires no specialized hardware. It displays digitized MEG signals, topographic maps, etc. It displays electrical brain activity correlated to anatomical brain information, which is provided by means of either an idealized head model and an idealized MRI image or a subject's MRI image based head model and the subject's MRI images. These functions are all controlled and interpreted by the user. The MaxInsight software imports digital MEG and co-registered EEG data (in the Neuromag Functional Image File Format) and permits its visualization. The digitized MEG/EEG input is read from a file on the personal computer (or available across the network). The software also provides a report generator to transfer relevant information, such as patient and recording information, event information, topographic images and images of brain activity, to a printable document.
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K Number
K051825Device Name
COGNITRACE
Manufacturer
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
Date Cleared
2005-09-12
(69 days)
Product Code
GWQ, AND, GWE
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to record and display EEG and EP (evoked potential) data in the clinic and hospital. It is intended to aid in the diagnosis and monitoring of potential disorders of the central and peripheral nervous system.
Device Description
Cognitrace provides a comprehensive EEG/ERP Data acquisition and analysis System. Cognitrace consists of the following components: 1 EEG/ERP amplifier, Power supply for EEG/ERP amplifier, eemagine EEG (K002631) software with Cognitrace extension modules, Stimulation unit. Cognitrace can perform complete sets of measurements for neurology and psychiatry: EEG, Visual Evoked Potential (VEP), Auditory Evoked Potential (AEP), P300 (Auditory oddball paradigm), Visual P300 (Visual oddball paradigm), CNV (Contingent Negative Variation), Option to add protocols using acoustic or visual stimulation. The software components are: eemagine EEG, a novel, user-friendly and efficient software package for the analysis of EEG data and eego, a novel, user-friendly EEG data acquisition system and allows you to record and review EEG, offering different amplifier configurations, eego is seemlessly integrated with the eemagine EEG software, which offers simplicity and efficiency in the analysis of EEG studies.
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K Number
K002631Device Name
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
Manufacturer
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
Date Cleared
2000-10-23
(61 days)
Product Code
OLX
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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