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510(k) Data Aggregation

    K Number
    K143487
    Device Name
    Lifelines iEEG
    Manufacturer
    KVIKNA EHF
    Date Cleared
    2015-08-21

    (256 days)

    Product Code
    OLT, GWQ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    KVIKNA EHF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lifelines iEEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information. The Lifelines iEEG system also includes the display of a quantitative EEG plots, power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.
    Device Description
    Lifelines iEEG is medical device used to acquire, display, archive, store and analyze EEG examinations. 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 acquiring and 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 system 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 components of Lifelines iEEG are: - Lifelines iEEG software: - . iEEG Centrum - . iEEG Review - iEEG Acquisition . - Lifelines Trackit, Lifelines Ltd, 510(k)#K010460 - Lifelines Photic Stimulator, Lifelines Ltd, 510(k)# K101691 ● - Off the shelf PC and medical grade power supply ● - Off the shelf IP Video Camera ●
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    K Number
    K123665
    Device Name
    LIFELINES IEEG
    Manufacturer
    KVIKNA EHF
    Date Cleared
    2013-03-25

    (117 days)

    Product Code
    OLT
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    KVIKNA EHF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lifelines iEEG is a software system that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. - The Lifelines iEEG software allows display, archive, review and analysis of . physiological signals. - Lifelines iEEG also includes the display of a quantitative EEG plot, power . spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.
    Device Description
    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 iEEG Review.
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