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510(k) Data Aggregation

    K Number
    K243020
    Device Name
    MIDASVu
    Manufacturer
    IntraVu, Inc.
    Date Cleared
    2024-12-02

    (66 days)

    Product Code
    HRX, GCJ
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    IntraVu, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIDASVu is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.
    Device Description
    MIDASVu is an advanced imaging system comprised of sterile, single-use scopes (0° and 30° viewing angle) and a reusable tablet. The scopes include camera and image capture features with LED light source. The distal tip of the scopes contains the camera, illumination, and imaging optics. The scopes are available in three lengths: 60mm, 90mm, and 120mm. The scopes and tablet work in concert as a system to acquire, display and record an intra-articular image as well as store images and video taken during the procedure.
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    K Number
    K181982
    Device Name
    MIDAScope and Introducer Kit, and MIDASystem
    Manufacturer
    IntraVu, Inc.
    Date Cleared
    2018-08-21

    (27 days)

    Product Code
    HRX, GCJ
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    IntraVu, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIDAScope™ and Introducer Kit, and MIDASystem™ are indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.
    Device Description
    The MIDAScope™ is a miniaturized, sterile, single-use disposable scope. The image is acquired by an image sensor located at the distal tip. Illumination is provided by an LED and fibers when the disposable scope is connected to the reusable MIDASystem™ via an electrical cable. The scope is available in different lengths to accommodate different treatment locations. The scope is introduced into the joint space using the IntraVu disposable Introducer Kit, consisting of a cannula, trocar and stopcock, which are provided sterile in the same package as the scope. The MIDASystem™ is a reusable device consisting of an integrated LCD display, and software that receives, processes and displays the images collected by the scope.
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