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510(k) Data Aggregation

    K Number
    K023061
    Device Name
    KONICA DIRECT DIGITIZER REGIUS, MODEL 170
    Manufacturer
    KONICA MINOLTA MEDICAL & GRAPHIC, INC.
    Date Cleared
    2002-10-11

    (25 days)

    Product Code
    MQB,MOB
    Regulation Number
    892.1680
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K023061
    Why did this record match?
    Device Name :

    KONICA DIRECT DIGITIZER REGIUS, MODEL 170

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Konica Direct Digitizer Model 170 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) substantial equivalence letter for a medical device called "Direct Digitizer REGIUS Model 150" and "Konica Direct Digitizer Model 170." It does not contain any information about acceptance criteria, device performance, a study conducted, sample sizes, ground truth establishment, or expert involvement.

    The letter primarily focuses on the regulatory aspects of device approval, stating that the device is substantially equivalent to a legally marketed predicate device. It confirms that the device can be marketed subject to general controls and potential additional special controls.

    Therefore, I cannot provide the requested information based on the input text.

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