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510(k) Data Aggregation

    K Number
    K062376
    Device Name
    DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
    Manufacturer
    RF SYSTEMS LAB.
    Date Cleared
    2006-10-27

    (73 days)

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

    DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI

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

    The Direct Digital Radiography CCD Imaging Sensor, NAOMI provides digital image capture for conventional film / screen radiographic examinations. The device is intended to replace radiographic film / screen systems in all general-purpose diagnostic procedures. "The device must not be used for primary diagnosis in mammography."

    Device Description

    Direct Digital Radiography CCD Imaging Sensor NAOMI

    AI/ML Overview

    I am sorry but this document is a 510(k) substantial equivalence letter from the FDA. It does not contain information on the acceptance criteria, study details, or performance of the device. It primarily discusses the regulatory classification of the "Direct Digital Radiography CCD Imaging Sensor NAOMI" and its substantial equivalence to previously marketed devices. Therefore, I cannot provide the requested information based on this document.

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