Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K003442
    Device Name
    MODIFICATION TO EDI VERIS SYSTEM
    Manufacturer
    ELECTRO-DIAGNOSTIC IMAGING, INC.
    Date Cleared
    2001-05-04

    (179 days)

    Product Code
    HLX
    Regulation Number
    886.1630
    Why did this record match?
    Product Code :

    HLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K983983
    Device Name
    EDI VERIS SYSTEM
    Manufacturer
    ELECTRO-DIAGNOSTIC IMAGING, INC.
    Date Cleared
    1999-02-03

    (86 days)

    Product Code
    HLX
    Regulation Number
    886.1630
    Why did this record match?
    Product Code :

    HLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VERIS system is an electodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG) and visual evoked potential (VEP) signals, power spectra, and topographic maps. These functions are controlled and interpreted by trained medical professionals. The device is intended for use in the diagnosis and management of retinal ischemic diseases, diabetic retinopathy, and central or branch vein occlusion.
    Device Description
    Photic stimuli are presented to the patient on a CRT screen up to 60 degrees at 241 elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanisms and isolation of signal from different retinal layers. Data is acquired by 2 recording channels using conventional EEG electrodes (not provided with the device). During the period of time that the system is acquiring data (4-16 minutes), there is a real time display of the raw and processed data presented to the user. Once the resulting individual waveforms are acquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topographical representations.
    Ask a Question

    Page 1 of 1