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510(k) Data Aggregation

    K Number
    K980873
    Device Name
    KONICA DIRECT DIGITIZER REGIUS MODEL 330
    Manufacturer
    KONICA CORP.
    Date Cleared
    1998-06-19

    (105 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KONICA DIRECT DIGITIZER REGIUS MODEL 330

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

    Reading, processing, displaying and printing X-ray images from exposed photostimulable phosphor plates.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Konica Direct Digitizer Regius Model 330. It does not contain any information about acceptance criteria or a study proving device performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document is strictly a regulatory approval notice, indicating that the device has been deemed substantially equivalent to a predicate device.

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