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510(k) Data Aggregation

    K Number
    K974542
    Device Name
    TRUE VISION, TRUE VISION II
    Manufacturer
    MEDICAL DYNAMICS, INC.
    Date Cleared
    1998-02-17

    (76 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DYNAMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These intra-oral Dental Cameras are for use in dentistry to be able to show the patient abnormalities and pathology within the mouth. The cameras are utilized exclusively to inform the patient of conditions in the mouth which require treatment. It is not intended that the dental intra-oral camera be utilized in any dental operative procedure. The camera is provided NON-STERILE and the camera is not built so that it can tolerate any sterilization process. The camera system does provide a "clean", optically clear covering for the distal end of the handpiece. This provides a "clean" covering for the distal handpiece, and is intended for one time use only.
    Device Description
    Not Found
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