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510(k) Data Aggregation

    K Number
    K163558
    Device Name
    Synapsys Ulmer Video Nystagmograph
    Manufacturer
    Date Cleared
    2017-03-23

    (94 days)

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

    Synapsys SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ulmer Video Nystagmograph System is intended for use by the physician as an aid for the detection and diagnosis of vestibular disorders. The Ulmer VNG detects and displays eye position and movement in response to a number of vestibular stimulations i.e. saccadic test, smooth pursuit, optokinetic nystagmus, caloric tests and kinetic vestibular tests. The Ulmer VNG records and analyses the bilateral, monocular, horizontal and vertical aspects of eye position and movement. This device is intended to be used in a doctor's office or health care facility to obtain recorded data of nystagmus by directly observing eye motion by video cameras. The resulting recorded data is evaluated by a trained physician and considered along with other relevant data in diagnosing vestibular disorders.
    Device Description
    The Ulmer VNG is a video nystagmograph system composed by a software and hardware components. The software has optional modules: Caloric, Saccade, Slow Pursuit, Kinetic, Optokinetic, Nystagmus (Nystagmus, Gaze or Vertical Subjective modules). It is provided on a CD Rom and activated with a key licensing. The hardware components correspond to a video acquisition unit. The video acquisition unit is composed by different camera goggles/masks in order to allow the visualization of the movement of one or both eye of the patient. The types of cameras included are as follows: - -Type VNS (goggle camera wired), - -Type WNS (goggle camera wireless using Wifi), and - -Type VISIO (goggle camera for visual free field). For Kinetic Test, an optional stimulator system can be used and is composed by a speed sensor velocimeter and a rotating chair. The modified Ulmer VNG system is a modification of the previously cleared Synapsys Ulmer VNG System (K982103) which allows use of a wireless camera (using Wifi). The advantage of a wireless camera system resides in both ergonomics: manoeuvers made easier without being disturbed by cable presence; and portability: makes possible to bring a VNG system (PC laptop + wireless camera) to the patient unlike other fixed wired systems.
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