Lifelines iEEG Server Software

Primary DI
05694110063069
Brand
Lifelines iEEG Server Software
Company
Kvikna Medical ehf.
Model
KSW2060
Device description
Lifelines iEEG is software system used to manage and review EEG examinations. It works on dataacquired by third party EEG equipment that is imported into the system. The EEG is presented in aconventional way and conventional signal processing is applied such as re-montaging and band passfiltering. The system is also capable of presenting digital video synchronized to the EEG if this isavailable. 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 dataover WAN without the use of additional remote desktop software solutions. The two main componentsof Lifelines iEEG are iEEG Centrum and iEEC Review.
Published
2016-10-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OLTNon-Normalizing Quantitative Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123665000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123665000LIFELINES IEEGKvikna Ehf2013-03-25OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05694110063069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694110063069056941100630695694110063069

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA 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. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
500793540
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05694110063007Lifelines iEEG Portable Yoga Tablet WiredKHW10202016-08-18
05694110063014Lifelines iEEG Portable Yoga Tablet WirelessKHW10222016-08-18
05694110063021Lifelines iEEG Portable Laptop System WiredKHW10102016-08-18
05694110063038Lifelines iEEG Portable Laptop System WirelessKHW10302016-08-18
05694110063045Lifelines iEEG Portable Laptop System No VideoKHW10402016-08-18
05694110063076Lifelines iEEG Portable Yoga Tablet No VideoKHW10502016-10-03
05694110063083Lifelines iEEG Clinical Desktop SystemKHW2050 2017-05-04
05694110063090Lifelines iEEGAcquisition 2017-11-09
05694110068057Stratus EEGServer Software2021-01-28
05694110068064Stratus EEGClient Software2021-01-28
05694110068071Stratus EEGAcquisition 2021-01-28
05694110063052Lifelines iEEG Client SoftwareKSW20502016-10-03
05694110068040Stratus EEGWeb2020-09-01

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