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510(k) Data Aggregation

    K Number
    K042791
    Device Name
    INSTANT-X, MODELS 1713 & 128
    Manufacturer
    ANN ARBOR DIGITAL DEVICES
    Date Cleared
    2005-07-01

    (267 days)

    Product Code
    MQBMOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANN ARBOR DIGITAL DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Device is a digital X-Ray system intended for use in the field of diagnostic X-Ray. The resident physician would use this device just as if it were a film-based system.
    Device Description
    This device is called Instant-X and is available as Model 1713 and Model 128. This Device is a digital X-Ray system.
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