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510(k) Data Aggregation

    K Number
    K963913
    Device Name
    MD100 & MM150
    Manufacturer
    KONICA MEDICAL CORP.
    Date Cleared
    1997-10-08

    (373 days)

    Product Code
    EAM
    Regulation Number
    892.1960
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Accessory to a cassette to convert X-Ray energy into light energy.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Konica Intensifying Screens MD100 and MM150." This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria or specific study details as would be found in a clinical study report or a premarket approval (PMA) application.

    Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text. The document is a regulatory approval, not a scientific study report.

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