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510(k) Data Aggregation

    K Number
    K242726
    Device Name
    Synapsys VHIT
    Manufacturer
    Inventis S.r.l.
    Date Cleared
    2025-01-03

    (115 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inventis S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synapsys VHIT is a medical device designed to assess the vestibular-ocular-reflex (VOR) by measuring, recording, displaying, and analyzing eye and head movements.
    Device Description
    Synapsys VHT (Video Head Impulse Test) allows to assess the vestibular-ocular-reflex (VOR) by measuring, and analyzing eye and head movements. Synapsys VHT does not require the patient to wear goggles, since it consists of a remote camera placed 90 cm from the subject, framing the subject's eyes and head. The device features real-time eyes detection and tracking, thanks to a built-in infrared illuminator hat lights up the subject. Head displacements are retrieved using algorithms that extract motion data from real time images recorded by the camera.
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