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510(k) Data Aggregation

    K Number
    K990359
    Device Name
    KONICA DIRECT DIGITIZER, MODEL DD-341
    Manufacturer
    KONICA CORP.
    Date Cleared
    1999-08-17

    (193 days)

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

    KONICA DIRECT DIGITIZER, MODEL DD-341

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

    The Konica Direct Digitizer (Computed Radiography Device) Model DD-341/Regius 150 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

    Konica Direct Digitizer, Model DD-341/Regius 150 is a Computed Radiography Device.

    AI/ML Overview

    This document is a 510(k) clearance letter for the Konica Direct Digitizer, Model DD-341/Regius 150. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter acknowledges the company's intent to market the device and states that the FDA has determined it is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies from the provided text.

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