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510(k) Data Aggregation

    K Number
    K051418
    Device Name
    DIRECT DIGITIZER REGIUS MODEL 370
    Manufacturer
    KONICA MINOLTA MEDICAL & GRAPHIC, INC.
    Date Cleared
    2005-07-01

    (30 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIRECT DIGITIZER REGIUS MODEL 370

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

    The Direct Digitizer, REGIUS MODEL 370 is an X-ray image controller which uses a Simulative phosphor as X-ray detector and intended to control and manages digital X-ray image file processing. The REGIUS MODEL 370 is NOT intended for use with digital mammography system.

    Device Description

    The Direct Digitizer, REGIUS MODEL 370 is an X-ray image controller which uses a Simulative phosphor as X-ray detector and intended to control and manages digital X-ray image file processing.

    AI/ML Overview

    I am sorry, but the provided document does not contain information about acceptance criteria and a study that proves the device meets those criteria. The document is a 510(k) clearance letter for the Direct Digitizer REGIUS Model 370, which confirms its substantial equivalence to legally marketed predicate devices and outlines its intended use. It does not include details on specific performance acceptance criteria, study methodologies, or results.

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