DEVICE: Lifelines iEEG Server Software (05694110063069)

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Device Identifier (DI) Information

Lifelines iEEG Server Software
KSW2060

Kvikna Medical ehf.
05694110063069
GS1
1
Lifelines iEEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions. The two main components of Lifelines iEEG are iEEG Centrum and iEEC Review.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Bioelectrical signal analysis software A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server.
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FDA Product Code

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Product Code Product Code Name
OLT Non-Normalizing Quantitative Electroencephalograph Software
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Sterilization

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Storage and Handling

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Clinically Relevant Size

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Device Status

In Commercial Distribution
October 03, 2016

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Alternative and Additional Identifiers Additional Identifiers

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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